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1.  Approach to urinary tract infections 
Indian Journal of Nephrology  2009;19(4):129-139.
Urinary tract infection (UTI) is the most common infection experienced by humans after respiratory and gastro-intestinal infections, and also the most common cause of both community-acquired and nosocomial infections for patients admitted to hospitals. For better management and prognosis, it is mandatory to know the possible site of infection, whether the infection is uncomplicated or complicated, re-infection or relapse, or treatment failure and its pathogenesis and risk factors. Asymptomatic bacteriuria is common in certain age groups and has different connotations. It needs to be treated and completely cured in pregnant women and preschool children. Reflux nephropathy in children could result in chronic kidney disease; otherwise, urinary tract infections do not play a major role in the pathogenesis of end-stage renal disease. Symptomatic urinary tract infections occur most commonly in women of child-bearing age. Cystitis predominates, but needs to be distinguished from acute urethral syndrome that affects both sexes and has a different management plan than UTIs. The prostatitis symptoms are much more common than bacterial prostatic infections. The treatment needs to be prolonged in bacterial prostatitis and as cure rates are not very high and relapses are common, the classification of prostatitis needs to be understood. The consensus conference convened by National Institute of Health added two more groups of patients, namely, chronic prostatitis/chronic pelvic pain syndrome and asymptomatic inflammatory prostatitis, in addition to acute and chronic bacterial prostatitis. Although white blood cells in urine signify inflammation, they do not always signify UTI. Quantitative cultures of urine provide definitive evidence of UTI. Imaging studies should be done 3-6 weeks after cure of acute infection to identify abnormalities predisposing to infection or renal damage or which may affect management. Treatment of cystitis in women should be a three-day course and if symptoms are prolonged, then a seven day course of antibiotics should be given. Selected group of patients benefits from low-dose prophylactic therapy. Upper urinary tract infection may need in-patient treatment. Treatment of acute prostatitis is 30-day therapy of appropriate antibiotics and for chronic bacterial prostatitis a low dose therapy for 6-12 months may be required. It should be noted that no attempt should be made to eradicate infection unless foreign bodies such as stones and catheters are removed and correctable urological abnormalities are taken care of. Treatment under such circumstances can result only in the emergence of resistant organisms and complicate therapy further.
doi:10.4103/0971-4065.59333
PMCID: PMC2875701  PMID: 20535247
Acute urethral syndrome; bacteriuria; imaging studies; low-dose prophylaxis; urinary tract infection; urine culture
2.  Single-dose fosfomycin trometamol versus 5-day cephalexin regimen for treatment of uncomplicated lower urinary tract infections in women. 
Antimicrobial Agents and Chemotherapy  1994;38(11):2612-2614.
A randomized study was conducted to assess the clinical and microbiological efficacies of a single 3-g dose of fosfomycin trometamol for the treatment of uncomplicated lower urinary tract infections in women compared with a 5-day regimen of cephalexin at 0.5 g four times daily. One hundred twelve women, all of whom had documented infections with bacteria sensitive to both antibiotics, were included. Fifty-eight women received fosfomycin trometamol, and 54 women received cephalexin. The two groups did not differ in age, severity, or duration of current urinary tract infection, menstrual status, sexual activity, or use of contraceptives. Ninety percent of pathogens in the fosfomycin trometamol group and 81% in the cephalexin group were Escherichia coli (the difference is not significant [NS]). A clinical evaluation at the 5-day follow-up showed that 91% of the women in each group were free of symptoms, while five women in each group were considered therapy failures and were treated by another antibiotic course. A microbiological evaluation at the 5-day follow-up showed a 91% eradication rate in the fosfomycin trometamol group and an 83% eradication rate in the cephalexin group (NS). At the 1-month follow-up, a clinical evaluation demonstrated prolonged resolution in 86 and 78%, respectively, of the participating women (NS). A microbiological evaluation at 1 month demonstrated prolonged eradication in 47 (81%) women treated with fosfomycin trometamol and in 37 (68%) women treated with cephalexin (NS). Three and six women, respectively, had relapsed. No adverse reactions were reported by the fosfomycin trometamol-treated women, while three women treated with cephalexin reported mild adverse reactions but completed the study period. Fosfomycin trometamol in a single 3-g dose is as effective as a 5-day regimen of cephalexin for the treatment of uncomplicated lower urinary tract infection in women.
PMCID: PMC188250  PMID: 7872756
3.  Comparative double-blind study of cephalexin and co-trimoxazole in urinary tract infections. 
British Medical Journal  1976;1(6011):684-686.
Treatment with cephalexin 1 g twiec daily and cotrimoxazole 2 tablets twice daily was compared in a double-blind, randomised study of 100 women with urinary tract infections. CO-trimoxazole gave a significantly higher cure rate compared with cephalexin two and six weeks after the one-week course of treatment. The higher failure rate with cephalexin was not related to the age of the patient, presentation, pyelographic appearances, or type of organism in the initial infection. Among the failures all but one of the organisms were sensitive to cephalexin. With the dosage regimen and duration of treatment used in this study cotrimoxazole appears to be superior to cephalexin in the management of acute urinary infections.
PMCID: PMC1639094  PMID: 1252882
4.  Randomised controlled trial of nitrofurantoin versus placebo in the treatment of uncomplicated urinary tract infection in adult women. 
BACKGROUND: Urinary tract infections (UTIs) are very common and have been treated with apparent success with antimicrobials for many years. However, there is a paucity of placebo-controlled clinical trials. AIM: To measure the symptomatic and bacteriological short-term effect of nitrofurantoin treatment versus placebo, in the treatment of uncomplicated UTI in adult non-pregnant women. DESIGN OF STUDY: Randomised placebo-controlled trial in general practice. SETTING: Non-pregnant women, aged between 15 and 54 years old, consulting a general practitioner for symtoms suggestive of uncomplicated lower UTI and with pyuria (positive for leucocyte esterase test). METHOD: A dipslide was inoculated in first-void midstream urine and sent for examinion. The patients were randomised to receive nitrofurantoin 100 mg or placebo four times daily for three days. After three, seven, and 14 days a new dipslide was inoculated and symptoms of UTI were checked or improvement of symptoms and bacteriuria. RESULTS: Of 166 women consulting with symptoms suggestive for UTI, 78 had pyuia and agreed to participate in the study (the clinically suspected UTI group); of these, 40 received nitrofurantoin and 38 received placebo. The result for combined symptomatic improvement and cure after three days was 27/35 in the nitrofurantoin group and 19/35 in the placebo group (c2 with Yates' correction P = 0.008; number needed to treat [NNT] = 4.4, 95% confidence interval [CI] = 2.3 to 79). After seven days, combined improvement and cure was observed in 30/34 and 17/33 respectively (P = 0.003, NNT = 2.7, 95% CI = 1.8 to 6.0). At inclusion, 56 women had bacteriuria of > or = 10(5) CFU/ml (the bacteriologically proven UTI group). Of these, 29 received nitrofurantoin and 27 received placebo. After three days the bacteriological cure was 21/26 in the treatment group, compared with 5/25 in the placebo group (P < 0.001; NNT = 1.6, 95% CI= 1.2 to 2.6). After seven days the bacteriological cure rate was 17/23 in the intervention group and 9/22 in the placebo group (P = 0.05, NNT = 3, 95% CI = 1.7 to 17). CONCLUSION: In women with bacteriologically proven UTI, nitrofurantoin was significantly more effective than placebo in achieving bacteriological cure and symptomatic relief in just three days; this was still present after seven days. In patients with clinically suspected UTI the symptomatic effect was statistically significant after
PMCID: PMC1314413  PMID: 12236276
5.  The paradox of using a 7 day antibacterial course to treat urinary tract infections in the community. 
1. We have studied determinants of outcome of 7 day courses of treatment in 77 middle aged and elderly patients, in whom the general practitioner's diagnosis of urinary tract infections had been confirmed microbiologically. Bacteria were sensitive to cephalexin or trimethoprim. Where there was no preference, treatments were allocated randomly. Compliance was monitored using a pill box with a concealed electronic device which recorded openings of the box. 2. Prescribing trimethoprim, 200 mg twice daily, was more effective than cephalexin, 250 mg four times daily (cure rates 93 and 67%) (P less than 0.006). Those cured and not cured were not distinguished by age, gender, genitourinary history, or infecting organism. 3. Compliance as measured by box openings was worse for cephalexin than for trimethopim (P = 0.01). However, both totality and pattern of compliance were similar in patients cured and not cured by cephalexin. Thus rigid adherence to a conventional course did not promote cure: fewer doses could have been prescribed. 4. Estimating compliance is essential to clinical trials where medication is self-administered. Poor compliance may establish over exacting regimens. Counting box openings did overestimate compliance, but counting residual tablets overestimated it grossly: given the number of openings less than the ideal, there should have been 171 residual tablets, only 55 were found.
Images
PMCID: PMC1386559  PMID: 3190989
6.  Review of the literature and individual patients’ data meta-analysis on efficacy and tolerance of nitroxoline in the treatment of uncomplicated urinary tract infections 
BMC Infectious Diseases  2014;14:628.
Background
Nitroxoline, a hydroxychinoline derivate, has been used for many years to treat urinary tract infections (UTI). Many uncontrolled, but only few controlled clinical studies have been published. Four so far unpublished, controlled clinical studies were meta-analysed.
Methods
A narrative literature review was performed. In addition the individual patient data (IPD) of 466 females with uncomplicated UTI of four prospective, single blind, randomized, clinical studies with similar protocols using nitroxoline (250 mg tid) versus cotrimoxazole (960 mg bid) or norfloxacin (400 mg bid) as controls for 5 days (sporadic UTI) or 10 days (recurrent UTI) were meta-analysed. The primary aim was eradication of bacteriuria 7–13 days after end of therapy (test of cure). Clinical efficacy was determined by elimination of symptoms and safety by adverse events and laboratory tests.
Results
Reviewing a total of 26 uncontrolled, 2 controlled and one postmarketing studies including more than 11,000 patients, good efficacy and safety of nitroxoline could be confirmed. In the four unpublished controlled studies a total of 234 patients were treated orally with nitroxoline and 232 with controls. The safety of nitroxoline was very good and comparable to the controls (adverse events 9.4% vs 7.8%; p = 0.360). In the mMITT set (at least one outcome result), in the PP set (test of cure outcome) and in the modified PP set (missing test of cure rated failure) more than 90% of the patients showed eradication of bacteriuria with nitroxoline, which also met statistical non-inferiority compared to the controls (10% non-inferiority margin) in all three evaluation sets. The clinical efficacy was similar between the two treatment groups.
Conclusion
The IPD meta-analysis using objective parameters (elimination of bacteriuria) demonstrated equivalent efficacy (non-inferiority) of nitroxoline with the controls tested (cotrimoxazole, norfloxacin) in the treatment of uncomplicated UTI. Considering the good safety and efficacy of nitroxoline as also shown in many uncontrolled and observational studies and the world wide increase of resistance of uropathogens against cotrimoxazole and fluoroquinolones, but not against nitroxoline within the last 20 years, nitroxoline should be reconsidered as one of the first line antibiotics for the treatment of uncomplicated UTI.
doi:10.1186/s12879-014-0628-7
PMCID: PMC4262220  PMID: 25427651
Nitroxoline; Cotrimoxazole; Norfloxacin; Uncomplicated urinary tract infection; Meta-analysis
7.  Single-dose and three-day regimens of ofloxacin versus trimethoprim-sulfamethoxazole for acute cystitis in women. 
We compared the safety and efficacy of a single 400-mg dose of ofloxacin, ofloxacin (200 mg) once daily for 3 days, and trimethoprim-sulfamethoxazole (160:800 mg) twice daily for 7 days for the treatment of acute uncomplicated cystitis (urinary tract infection [UTI]) in women. At 5 weeks posttreatment, 35 (81%) of 43 patients treated with single-dose ofloxacin, 40 (89%) of 45 treated with 3 days of ofloxacin, and 41 (98%) of 42 treated with trimethoprim-sulfamethoxazole were cured (P = 0.03, single-dose ofloxacin group versus trimethoprim-sulfamethoxazole group). Retreatment for symptomatic recurrent UTI was given to 7 (16%) of 43 patients initially treated with single-dose ofloxacin, 3 (7%) of 45 patients treated with 3 days of ofloxacin, and 0 of 42 patients treated with trimethoprim-sulfamethoxazole (P = 0.01, single-dose ofloxacin group versus trimethoprim-sulfamethoxazole group). There was a trend in each of the three treatment groups toward an association between persistent or recurrent episodes of significant bacteriuria and a history of UTI in the past year and with diaphragm use. Ofloxacin was more effective than trimethoprim-sulfamethoxazole in eradicating Escherichia coli from rectal cultures during or soon after therapy, but there were no differences at later follow-up visits. Adverse effects were equally common among the three treatment groups. We conclude that single-dose ofloxacin was less effective than 7 days of trimethoprim-sulfamethoxazole for treatment of uncomplicated cystitis in women, while the 3-day ofloxacin regimen and the trimethoprim-sulfamethoxazole regimen were not significantly different in efficacy.
PMCID: PMC245194  PMID: 1929311
8.  Clinical and bacteriological outcome of different doses and duration of pivmecillinam compared with placebo therapy of uncomplicated lower urinary tract infection in women: The LUTIW project 
Objective
To analyse associations between symptoms and bacteriuria in uncomplicated lower urinary tract infection in women (LUTIW) and to evaluate outcome of therapy with three different regimens of pivmecillinam or placebo.
Design
Prospective, multicentre, randomized, double-blind, and placebo-controlled therapy study. Symptoms registered at inclusion, during therapy and at follow-up visits after 8–10 and 35–49 days. Significant bacteriuria defined according to current European guidelines.
Setting
A total of 18 primary healthcare centres in northern Sweden.
Subjects
Women aged 18 years and above with symptoms of urgency, dysuria, supra pubic or loin pain.
Main outcome measures
Symptoms and bacteriuria at inclusion and course of symptoms, bacteriuria, and their combinations during and post-therapy.
Results
At inclusion, no associations or significant differences were found between symptom scores and bacteriuria, bacterial counts, or species. The 884 patients (77%) with significant bacteriuria were followed up. All pivmecillinam therapies were superior to placebo (p < 0.001). From day six until first follow-up, the mean values of all symptoms were higher and the bacteriological cure was lower at first follow-up in the three days (84%) compared with the seven days regimens (93–94%, p < 0.001). At final follow-up clinical cure was similar in all pivmecillinam regimens (65–72%) as was bacteriological cure (83–89%). Pivmecillinam had few low to mild adverse reactions, comparable to placebo.
Conclusions
Symptoms are not conclusive for diagnosis of LUTIW. Pivmecillinam therapies are superior to placebo and seven days regimens are more efficient than three days. Pivmecillinam 200 mg×2×7 days is recommended as a first-line therapy for LUTIW.
doi:10.1080/02813430601183074
PMCID: PMC3389454  PMID: 17354160
Bacteriuria; family practice; pivmecillinam; placebo; symptoms; therapy study; urinary tract infection
9.  Comparative study of amoxicillin-clavulanic acid and cephalexin in the treatment of bacteriuria during pregnancy. 
A comparative clinical trial of amoxicillin-clavulanic acid and cephalexin was carried out in 80 women with bacteriuria of pregnancy. Treatment was randomly allocated and consisted of either one tablet of amoxicillin plus clavulanic acid (250 and 125 mg, respectively) three times daily or cephalexin (250 mg) three times daily for 7 days. Overall bacteriological cure rates at 2 weeks were 77% in the amoxicillin-clavulanic acid group and 74% in the cephalexin group. At 6 weeks the respective rates were 76 and 60%. Twenty-five episodes of infection were with ampicillin-resistant strains; cure rates were 82% (2 weeks) and 80% (6 weeks) in the amoxicillin-clavulanic acid group and 85 and 64%, respectively, in the cephalexin group. Differences in cure rates were not statistically significant. No significant difference in the rate of side effects was found. In particular, no toxicity to the fetus was seen which could be ascribed to either drug. Amoxicillin-clavulanic acid would appear to be a safe and effective treatment for bacteriuria of pregnancy.
PMCID: PMC180085  PMID: 4004191
10.  Urinary tract infections and antimicrobial sensitivity among diabetic patients at Khartoum, Sudan 
Background
Patients with diabetes mellitus (DM) are more susceptible to urinary tract infection (UTI) than non-diabetics. Due to the emergence of multidrug resistant (MDR) uropathogenic strains, the choice of antimicrobial agent is restricted. This study investigated the epidemiology of UTI, antimicrobial susceptibility, and resistance patterns of bacterial isolates from adult diabetic patients.
Methods
A cross-sectional study was conducted at Khartoum Hospital, Sudan during the period of March − September 2013. Consecutive patients (men and women) were approached to participate in the study, irrespective of UTI symptoms. Socio-demographic and clinical data were obtained from each participant using pre-tested questionnaires. Clean-catch, midstream urine samples were collected and cultured for UTI diagnosis and antimicrobial susceptibility. Symptomatic bacteriuria was defined as a positive urine culture (≥105 colony-forming units [CFU]/mL of a single bacterial species) from patients with symptoms associated with UTI; asymptomatic bacteriuria was defined as a positive urine culture from patients without symptoms associated with UTI.
Results
A total of 200 diabetic patients were enrolled, 121 (60.5%) men and 79 (39.5%) women; 193 (96.5%) had type II DM. The overall prevalence of UTI was 39 (19.5%). Among the total population, 17.1% and 20.9% had symptomatic and asymptomatic bacteriuria, respectively. According to multivariate logistic regression, none of the investigated factors (age, sex, type of DM and duration) were associated with UTI. The predominant isolates were Escherichia coli (22, [56.4%]), and Klebsiella pneumoniae, [9, (23%)]. Eight of 22 E. coli, four of nine K. pneumoniae and one of five Enterococcus faecalis isolates originated from symptomatic patients. Six, four, three, and two of 22 E. coli isolates showed resistance to ampicillin, co-trimoxazole, nitrofurantoin, and amoxicillin-clavulanic acid, respectively. Two, two, one and one of nine K. pneumoniae isolates were resistant to ampicillin, co-trimoxazole, cephalexin, and amoxicillin-clavulanic acid. All 22 E. coli isolates were sensitive (100%) to gentamicin and cephalexin. All nine K. pneumoniae were sensitive to gentamicin (100%) and 88.8% were sensitive to cephalexin.
Conclusion
In Sudan, about one-fifth of diabetic patients have UTI. E. coli is the most frequent isolate followed by K. pneumoniae.
doi:10.1186/s12941-015-0082-4
PMCID: PMC4406170  PMID: 25896611
Diabetes; Urinary tract infection; Bacteriuria; E. coli; K. pneumoniae; Sudan
11.  Randomized, double-blind comparison of single-dose regimens of rufloxacin and pefloxacin for acute uncomplicated cystitis in women. French Multicenter Urinary Tract Infection-Rufloxacin Group. 
In a double-blind, randomized, multicenter study, 463 adult women with symptomatic acute uncomplicated cystitis were treated orally with either a 400-mg single dose of rufloxacin (n = 226) or an 800-mg single dose of pefloxacin (n = 237). Escherichia coli (78%) and Proteus mirabilis (7%) were the most common isolates from 350 patients with significant pretreatment bacteriuria (uropathogens, > or = 10(5) CFU/ml). In the intention-to-treat analysis of patients with significant pretreatment bacteriuria, 343 patients were assessed for bacteriological outcome and 345 were assessed for clinical outcome. The bacteriological cure rate was 88% in the rufloxacin group and 84% in the pefloxacin group (95% confidence interval [CI] for difference in proportions, -4 to 12%), while the clinical resolution rate was 85 and 84%, respectively (95% CI, -8 to 9%). The per-protocol analysis demonstrated that among the 264 assessable patients, the bacteriological cure rate obtained with rufloxacin at 4 weeks of follow-up was comparable to that with pefloxacin (91 versus 85%; 95% CI, -3 to 15%). Among 295 clinically assessable patients, the clinical resolution rate at 4 weeks of follow-up was 89% in the rufloxacin group and 88% in the pefloxacin group (95% CI, -6 to 10%). Potentially drug-related adverse events occurred in 19% of the rufloxacin patients and in 18% of the pefloxacin patients. A single oral dose of 400 mg of rufloxacin is as effective and safe as a single oral dose of 800 mg of pefloxacin for the treatment of acute uncomplicated cystitis in women.
PMCID: PMC162511  PMID: 7695309
12.  Single-dose cefuroxime axetil versus multiple-dose cefaclor in the treatment of acute urinary tract infections. 
Eighty-nine college women with acute urinary tract infections were treated orally with either 1,000 mg of cefuroxime axetil in a single dose (n = 59) or 250 mg of cefaclor three times a day for 7 days (n = 30). At 1 week posttherapy, 88% of the patients in the cefuroxime axetil group and 97% in the cefaclor group were clinically and bacteriologically cured (P greater than 0.10). There was no statistically significant difference between the cure rates of the two treatment groups. However, this study has only a 50% power to detect a 10% difference. Therefore, there is a substantial possibility of a type II error, i.e., failing to find a difference that is actually present. At 4 weeks posttherapy, 78% of the patients in the cefuroxime group and 80% in the cefaclor group remained cured. By 36 weeks posttherapy, the cumulative rate of recurrence in both treatment groups was 60%. Of the patients with a positive antibody-coated bacteria test, fewer achieved a short-term cure after single-dose treatment with cefuroxime axetil than those with a negative antibody-coated bacteria test (67 versus 96%; P less than 0.01).
PMCID: PMC172627  PMID: 2802549
13.  Urinary Tract Infections in Older Women 
JAMA  2014;311(8):844-854.
IMPORTANCE
Asymptomatic bacteriuria and symptomatic urinary tract infections (UTIs) in older women are commonly encountered in outpatient practice.
OBJECTIVE
To review management of asymptomatic bacteriuria and symptomatic UTI and review prevention of recurrent UTIs in older community-dwelling women.
EVIDENCE REVIEW
A search of Ovid (Medline, PsycINFO, Embase) for English-language human studies conducted among adults aged 65 years and older and published in peer-reviewed journals from 1946 to November 20, 2013.
RESULTS
The clinical spectrum of UTIs ranges from asymptomatic bacteriuria, to symptomatic and recurrent UTIs, to sepsis associated with UTI requiring hospitalization. Recent evidence helps differentiate asymptomatic bacteriuria from symptomatic UTI. Asymptomatic bacteriuria is transient in older women, often resolves without any treatment, and is not associated with morbidity or mortality. The diagnosis of symptomatic UTI is made when a patient has both clinical features and laboratory evidence of a urinary infection. Absent other causes, patients presenting with any 2 of the following meet the clinical diagnostic criteria for symptomatic UTI: fever, worsened urinary urgency or frequency, acute dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness. A positive urine culture (≥105 CFU/mL) with no more than 2 uropathogens and pyuria confirms the diagnosis of UTI. Risk factors for recurrent symptomatic UTI include diabetes, functional disability, recent sexual intercourse, prior history of urogynecologic surgery, urinary retention, and urinary incontinence. Testing for UTI is easily performed in the clinic using dipstick tests. When there is a low pretest probability of UTI, a negative dipstick result for leukocyte esterase and nitrites excludes infection. Antibiotics are selected by identifying the uropathogen, knowing local resistance rates, and considering adverse effect profiles. Chronic suppressive antibiotics for 6 to 12 months and vaginal estrogen therapy effectively reduce symptomatic UTI episodes and should be considered in patients with recurrent UTIs.
CONCLUSIONS AND RELEVANCE
Establishing a diagnosis of symptomatic UTI in older women requires careful clinical evaluation with possible laboratory assessment using urinalysis and urine culture. Asymptomatic bacteriuria should be differentiated from symptomatic UTI. Asymptomatic bacteriuria in older women should not be treated.
doi:10.1001/jama.2014.303
PMCID: PMC4194886  PMID: 24570248
14.  Efficacy and Safety of a Novel Once-Daily Extended-Release Ciprofloxacin Tablet Formulation for Treatment of Uncomplicated Urinary Tract Infection in Women 
Antimicrobial Agents and Chemotherapy  2005;49(10):4137-4143.
The efficacy and safety of a novel once-daily extended-release ciprofloxacin (ciprofloxacin ER) 500-mg dose were compared with those of an immediate-release ciprofloxacin (ciprofloxacin IR) 250-mg twice-daily dose, each administered orally for 3 days in the treatment of acute uncomplicated urinary tract infection (uUTI) in women. Adult female outpatients (mean age, 39 years) with clinical signs and symptoms of acute uUTI and a positive pretreatment urine culture (≥105 CFU/ml) were enrolled in a multicenter, randomized, double-blind, noninferiority trial. Patients were assessed at a test-of-cure visit (4 to 11 days posttreatment) and a late-posttreatment visit (4 to 6 weeks posttreatment) for microbiological and clinical outcomes and safety. The primary efficacy endpoint and microbiological eradication rate at the test-of-cure visit in the ciprofloxacin ER group (254/272; 93.4%) were noninferior to those in the ciprofloxacin IR group (225/251; 89.6%) (95% confidence interval [CI] of difference, −0.99%, 8.59%). Clinical-cure rates at the test-of-cure visit were 85.7% (233/272) for ciprofloxacin ER and 86.1% (216/251) for ciprofloxacin IR (95% CI of difference, −6.37%, 5.57%). At the late-posttreatment visit, microbiological and clinical outcomes were similar for the two treatments and consistent with test-of-cure results. Both treatments were well tolerated, but the frequencies of nausea and diarrhea were lower in the ciprofloxacin ER group than in the ciprofloxacin IR group (nausea, ER, 0.6%; IR, 2.2%; P = 0.033; diarrhea, ER, 0.2%; IR, 1.4%; P = 0.037). Once-daily ciprofloxacin ER was safe, effective, and noninferior to twice-daily ciprofloxacin IR in the treatment of acute uUTI. Additionally, ciprofloxacin ER was associated with significantly reduced frequencies of nausea and diarrhea.
doi:10.1128/AAC.49.10.4137-4143.2005
PMCID: PMC1251530  PMID: 16189090
15.  Single-dose amoxicillin therapy of acute uncomplicated urinary tract infections in women. 
Of 210 women who were experiencing dysuria, frequent urination, pyuria, and significant bacteriuria and who were treated with a single 3-g dose of amoxicillin, 165 (79%) were cured of their original infections. Patients with infections that were negative by antibody-coated-bacteria assay were cured at a significantly higher rate than those with infections that were positive by antibody-coated-bacteria assay (90 versus 59%; P less than 0.001). Similarly, those with infections caused by amoxicillin-susceptible organisms were cured at a significantly higher rate than those with infections caused by resistant organisms (85 versus 50%; P less than 0.001). Of 27 patients who had infections caused by amoxicillin-susceptible organisms and who had relapses after single-dose therapy, 14 (52%) had relapses again after a conventional 10-day course of therapy, although all responded to a 6-week course. An additional 27 patients experiencing dysuria, frequent urination, and pyuria but who had a lower number of uropathogens in the urine (10(2) to 10(4.5)/ml of urine) were treated with single-dose therapy, with a 100% eradication of organisms and an 89% rate of symptomatic relief.
PMCID: PMC185601  PMID: 6732229
16.  Treatment of Community-Acquired Acute Uncomplicated Urinary Tract Infection with Sparfloxacin versus Ofloxacin 
The efficacy and safety of a 3-day regimen of sparfloxacin were compared with those of a 3-day regimen of ofloxacin for the treatment of community-acquired acute uncomplicated urinary tract infections. Four hundred nineteen women were enrolled in a randomized, open-label, observer-blinded, multicenter study; 204 received sparfloxacin as a 400-mg loading dose on the first day and 200 mg once daily thereafter, and 215 received ofloxacin as 200 mg twice daily. A total of 383 patients met the criteria for clinical evaluability, and 174 were also bacteriologically evaluable; all treated patients were included in the safety analysis. Escherichia coli (86%) and Staphylococcus saprophyticus (4.6%) were the organisms most commonly isolated. Positive clinical responses were obtained 5 to 9 days after therapy in more than 92% of the patients in each group; sustained clinical cure rates 4 to 6 weeks after therapy were 78.3 and 76.9% in the sparfloxacin and ofloxacin groups, respectively. A positive bacteriologic response was observed in 98% of the bacteriologically evaluable patients in each treatment group at 5 to 9 days posttherapy and in 88.2 and 92.6% of the patients in the sparfloxacin and ofloxacin groups, respectively, 4 to 6 weeks after therapy. Almost 90% of all adverse events were of mild or moderate severity; the most frequent events at least possibly related to drug treatment were those common to the fluoroquinolones, namely, nausea, diarrhea, headache, insomnia, and photosensitivity. Photosensitivity was more frequent in the sparfloxacin group (6.9% versus 0.5% in the ofloxacin group); insomnia was more frequent in the ofloxacin group (3.7% versus 1.0% in the sparfloxacin group). These data suggest that a once-daily, 3-day regimen of sparfloxacin is effective and generally well tolerated in the treatment of acute uncomplicated urinary tract infections.
PMCID: PMC105806  PMID: 9736546
17.  Bacteriuria and primary biliary cirrhosis. 
Gut  1984;25(2):133-137.
Significant bacteriuria was found in 19% of 87 women with primary biliary cirrhosis, whereas in 89 women with other types of chronic liver disease bacteriuria was present in only 7%. In 74 women with rheumatoid arthritis 8% were bacteriuric. Midstream urine specimens obtained from 144 consecutive women with primary biliary cirrhosis attending hospital over a two year period showed that 50 (35%) developed bacteriuria during 12 months of follow up. Bacteriuria was unrelated to age, raised serum bilirubin, drug therapy or urinary pH but was more common in patients with late stage (fibrotic) disease as judged by histological criteria. Fifty seven per cent of bacteriuric primary biliary cirrhosis patients suffered more than one urinary infection. Fifty nine per cent of the 156 bacteriuric episodes were asymptomatic. The types of organism isolated, the antibiotic sensitivity patterns and cure rate were similar to those reported in bacteriuric women without other underlying disease. The reinfection rate (34%), however, was double that reported for bacteriuric episodes in 'problem' women with recurrent bacteriuria, indicating a special susceptibility to urinary infection. The most common isolates were E coli (70%), which did not show abnormal adhesiveness to uroepithelial or buccal cells of normal women, or to those of primary biliary cirrhosis patients. Patients with primary biliary cirrhosis have not been reported to be more susceptible to infection in general. Bacteriuria, however, was common throughout all clinical stages of primary biliary cirrhosis. Thus there may be a unique association between bacteriuria and primary biliary cirrhosis.
PMCID: PMC1432247  PMID: 6363217
18.  Prospective comparison of amoxicillin-clavulanic acid and cefaclor in treatment of uncomplicated urinary tract infections. 
Patients with acute, uncomplicated urinary tract infections were treated with either amoxicillin-clavulanic acid (A-C) in fixed combination or cefaclor for 10 days in a prospective randomized comparison. The A-C group included 29 women and 1 man (mean age, 25.5 years), and the cefaclor group included 35 women and 1 man (mean age, 24.9 years). The cure rates were 26 (87%) of 30 with A-C and 26 (72%) of 36 with cefaclor (P greater than 0.20). There was one failure in each group, each caused by an isolate resistant to ampicillin. There were one relapse and two reinfections in the A-C group, compared with seven relapses and two reinfections in the cefaclor group. Side effects, including patients started on antibiotics but whose cultures did not confirm urinary tract infections, were diarrhea in 7 (16%) and rash in 1 (2%) of 44 A-C patients, compared with diarrhea in 1 (2%) and yeast vaginitis in 3 (6%) of 48 cefaclor patients. Although the A-C group had a greater proportion of antibody-coated bacterium-positive infections (22 versus 18 with cefaclor), there was a lower recurrence rate with fewer relapses in patients treated with A-C.
PMCID: PMC185931  PMID: 6362553
19.  Treatment of uncomplicated urinary tract infection in non-pregnant women 
Postgraduate Medical Journal  1972;48(556):69-75.
A study of placebo treatment of acute symptomatic urinary tract infection in non-pregnant women showed that about 80% obtained sterile urine spontaneously within 5 months. About one-half of these had recurrent infection within a year.
Antimicrobials produced a high immediate cure rate, but only 45% maintained sterile urine for 2 years. The recurrence rate was highest during the first 2 months after treatment, and thereafter nearly constant during the subsequent 20 months. Twenty-nine percent of recurrences were recrudescences and 71% reinfections. About one-sixth of the patients had a very high recurrence rate, 2·6 infections/year, as compared with 0·32/year in the remainder. Nearly all of these patients had their first recurrence within 5 months of the initial treatment. The probability of recurrence increased with the number of previous infections. Some patients, however, after a period with many recurrences, showed a remarkable decrease in recurrence rate.
If the aim of treatment is to keep periods of bacteriuria to a minimum, it is necessary to do frequent urine cultures for at least 6 months after elimination of bacteriuria.
PMCID: PMC2495172  PMID: 4552445
20.  Double-Blind Comparison of Carbenicillin Indanyl Sodium, Ampicillin, and Cephalexin in Treatment of Urinary Tract Infection 
Carbenicillin indanyl sodium, ampicillin, or cephalexin was administered orally to 61 patients with urinary tract infections. Assignment of drug was made by a computer-generated, randomized plan in a double-blind fashion. The rates of cure 4 weeks after therapy were 50, 42, and 50% for patients treated with carbenicillin, ampicillin, and cephalexin, respectively. Failure of therapy was correlated with chronicity of infection and sensitivity of the microorganism to the antibiotic used. Thirty-nine percent of the patients developed side effects, but there were no significant differences in side effects among the three antibiotics. This double-blind study demonstrates that carbenicillin indanyl sodium is as effective as ampicillin and cephalexin in treatment of urinary tract infections.
PMCID: PMC444602  PMID: 4602827
21.  Comparative trial of norfloxacin and trimethoprim-sulfamethoxazole in the treatment of women with localized, acute, symptomatic urinary tract infections and antimicrobial effect on periurethral and fecal microflora. 
Forty-three women with acute, symptomatic urinary tract infections were randomized to receive either norfloxacin (400 mg) twice daily or trimethoprim-sulfamethoxazole (160-800 mg) twice daily for 10 days. Of the 43 patients, 7 (16%) had low-count bacteriuria and pyuria and were included in the evaluation. Escherichia coli was isolated in 72% of the infections, whereas coagulase-negative staphylococci were isolated in 14%. All isolates were susceptible to the assigned study drug. The MICs for 90% of the strains susceptible to norfloxacin and trimethoprim-sulfamethoxazole were less than or equal to 2 and less than or equal to 0.8-16 micrograms/ml, respectively. The cure rates for norfloxacin and trimethoprim-sulfamethoxazole were 95 and 90%, respectively. There were 17 patients with presumptive upper tract infections; only 1 of these relapsed after therapy. The effects on the periurethral flora were similar in both groups, but the infecting organism was eradicated from the fecal flora in 93% of the patients treated with norfloxacin and in 57% of the patients treated with trimethoprim-sulfamethoxazole. More early reinfections occurred in the trimethoprim-sulfamethoxazole group, with resistant organisms appearing in urine and in the periurethral and fecal flora in all cases. Three patients in each group experienced adverse clinical effects, but these were more severe in the trimethoprim-sulfamethoxazole group. No adverse hematological or biochemical changes were noted. From these results, we concluded that norfloxacin is at least as effective as trimethoprim-sulfamethoxazole in the therapy of acute, symptomatic urinary tract infections in women.
PMCID: PMC179948  PMID: 6240223
22.  A Randomised Controlled Trial of Artemether-Lumefantrine Versus Artesunate for Uncomplicated Plasmodium falciparum Treatment in Pregnancy 
PLoS Medicine  2008;5(12):e253.
Background
To date no comparative trials have been done, to our knowledge, of fixed-dose artemisinin combination therapies (ACTs) for the treatment of Plasmodium falciparum malaria in pregnancy. Evidence on the safety and efficacy of ACTs in pregnancy is needed as these drugs are being used increasingly throughout the malaria-affected world. The objective of this study was to compare the efficacy, tolerability, and safety of artemether-lumefantrine, the most widely used fixed ACT, with 7 d artesunate monotherapy in the second and third trimesters of pregnancy.
Methods and Findings
An open-label randomised controlled trial comparing directly observed treatment with artemether-lumefantrine 3 d (AL) or artesunate monotherapy 7 d (AS7) was conducted in Karen women in the border area of northwestern Thailand who had uncomplicated P. falciparum malaria in the second and third trimesters of pregnancy. The primary endpoint was efficacy defined as the P. falciparum PCR-adjusted cure rates assessed at delivery or by day 42 if this occurred later than delivery, as estimated by Kaplan-Meier survival analysis. Infants were assessed at birth and followed until 1 y of life. Blood sampling was performed to characterise the pharmacokinetics of lumefantrine in pregnancy. Both regimens were very well tolerated. The cure rates (95% confidence interval) for the intention to treat (ITT) population were: AS7 89.2% (82.3%–96.1%) and AL 82.0% (74.8%–89.3%), p = 0.054 (ITT); and AS7 89.7% (82.6%–96.8%) and AL 81.2% (73.6%–88.8%), p = 0.031 (per-protocol population). One-third of the PCR-confirmed recrudescent cases occurred after 42 d of follow-up. Birth outcomes and infant (up to age 1 y) outcomes did not differ significantly between the two groups. The pharmacokinetic study indicated that low concentrations of artemether and lumefantrine were the main contributors to the poor efficacy of AL.
Conclusion
The current standard six-dose artemether-lumefantrine regimen was well tolerated and safe in pregnant Karen women with uncomplicated falciparum malaria, but efficacy was inferior to 7 d artesunate monotherapy and was unsatisfactory for general deployment in this geographic area. Reduced efficacy probably results from low drug concentrations in later pregnancy. A longer or more frequent AL dose regimen may be needed to treat pregnant women effectively and should now be evaluated. Parasitological endpoints in clinical trials of any antimalarial drug treatment in pregnancy should be extended to delivery or day 42 if it comes later.
Trial Registration: Current Controlled Trials ISRCTN86353884
Rose McGready and colleagues show that an artemether-lumefantrine regimen is well tolerated and safe in pregnant Karen women with uncomplicated falciparum malaria, but efficacy is inferior to artesunate, probably because of low drug concentrations in later pregnancy.
Editors' Summary
Background.
Plasmodium falciparum, a mosquito-borne parasite that causes malaria, kills nearly one million people every year. Although most deaths occur among young children, malaria during pregnancy is also an important public-health problem. In areas where malaria transmission is high (stable transmission), women acquire a degree of immunity. Although less symptomatic than women who lack natural protection, their babies are often small and sickly because malaria-related anemia (lack of red blood cells) and parasites in the placenta limit the nutrients supplied to the baby before birth. By contrast, in areas where malaria transmission is low (unstable transmission or sporadic outbreaks), women have little immunity to P. falciparum. If these women become infected during pregnancy, “uncomplicated” malaria (fever, chills, and anemia) can rapidly progress to “severe” malaria (in which vital organs are damaged), which can be fatal to the mother and/or her unborn child unless prompt and effective treatment is given.
Why Was This Study Done?
Malaria parasites are now resistant to many of the older antimalarial drugs (for example, quinine). So, since 2006, the World Health Organization (WHO) has recommended that uncomplicated malaria during the second and third trimester of pregnancy is treated with short course (3 d) fixed-dose artemisinin combination therapy (ACT; quinine is still used in early pregnancy because it is not known whether ACT damages fetal development, which mainly occurs during the first 3 mo of pregnancy). Artemisinin derivatives are fast-acting antimalarial agents that are used in combination with another antimalarial drug to reduce the chances of P. falciparum becoming resistant to either drug. The most widely used fixed-dose ACT is artemether–lumefantrine (AL) but, although several trials have examined the safety and efficacy of this treatment in non-pregnant women, little is known about how well it works in pregnant women. In this study, the researchers compare the efficacy, tolerability, and safety of AL with a 7-d course of artesunate monotherapy (AS7; another artemisinin derivative) in the treatment of uncomplicated malaria in pregnancy in northwest Thailand, an area with unstable but highly drug resistant malaria transmission.
What Did the Researchers Do and Find?
The researchers enrolled 253 women with uncomplicated malaria during the second and third trimesters of pregnancy into their open-label trial (a trial in which the patients and their health-care workers know who is receiving which drug regimen). Half the women received each type of treatment. The trial's main outcome was the “PCR-adjusted cure rate” at delivery or 42 d after treatment if this occurred after delivery. This cure rate was assessed by examining blood smears for parasites and then using a technique called PCR to determine which cases of malaria were new infections (classified as treatment successes along with negative blood smears) and which were recurrences of an old infection (classified as treatment failures). The PCR-adjusted cure rates were 89.7% and 81.2% for AS7 and AL, respectively. Both treatments were well tolerated, few side effects were seen with either treatment, and infant health and development at birth and up to 1 y old were similar with both regimens. Finally, an analysis of blood samples taken 7 d after treatment with AL showed that blood levels of lumefantrine were below those previously associated with treatment failure in about a third of the women tested.
What Do These Findings Mean?
Although these findings indicate that the AL regimen is a well tolerated and safe treatment for uncomplicated malaria in pregnant women living in northwest Thailand, the efficacy of this treatment was lower than that of artesunate monotherapy. In fact, neither treatment reached the 90% cure rate recommended by WHO for ACTs and it is likely that cure rates in a more realistic situation (that is, not in a trial where efforts are made to make sure everyone completes their treatment) would be even lower. The findings also suggest that the reduced efficacy of the AL regimen in pregnant women compared to the efficacy previously seen in non-pregnant women may be caused by lower drug blood levels during pregnancy. Thus, a higher-dose AL regimen (or an alternative ACT) may be needed to successfully treat uncomplicated malaria during pregnancy.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050253.
The MedlinePlus encyclopedia contains a page on malaria (in English and Spanish)
Information is available from the World Health Organization on malaria (in several languages), and their 2006 Guidelines for the Treatment of Malaria includes specific recommendations for the treatment of pregnant women
The US Centers for Disease Control and Prevention provide information on malaria and on malaria during pregnancy (in English and Spanish)
Information is available from the Roll Back Malaria Partnership on malaria during pregnancy, on artemisinin-based combination therapies, and on malaria in Thailand
doi:10.1371/journal.pmed.0050253
PMCID: PMC2605900  PMID: 19265453
23.  Study of use of cefdinir versus cephalexin for treatment of skin infections in pediatric patients. The Cefdinir Pediatric Skin Infection Study Group. 
Three hundred ninety-four patients, aged 6 months to 12 years, entered a multicenter, randomized, controlled, investigator-blind study comparing cefdinir, 7 mg/kg of body weight twice a day, with cephalexin, 10 mg/kg four times a day, each given for 10 days. The most common infections treated were impetigo and secondary infection of preexisting dermatitis. The most common pathogens isolated were Staphylococcus aureus and Streptococcus pyogenes. Two hundred thirty-one patients were microbiologically evaluable. Microbiologic eradication rates were 164 of 165 pathogens (99.4%) in the cefdinir group and 152 of 156 pathogens (97.4%) in the cephalexin group (P = 0.14). Clinical cure rates were 116 of 118 patients (98.3%) in the cefdinir group and 106 of 113 patients (93.8%) in the cephalexin group (P = 0.056). Sixteen percent of cefdinir patients and 11% of cephalexin patients experienced adverse events (P = 0.11), the most common being diarrhea, which affected 8% of the cefdinir group and 4% of the cephalexin group. Cefdinir appears to be an effective and well-tolerated agent for the treatment of uncomplicated skin and skin structure infections in pediatric patients.
PMCID: PMC163785  PMID: 9087480
24.  Epidemiology of urinary tract diseases in general practice 
British Medical Journal  1969;4(5680):390-394.
During a one-year morbidity survey of urinary tract diseases in general practice 741 cases were diagnosed. Only about half of all the patients with symptoms of urinary tract infection had significant bacteriuria. In young women urinary tract infections and symptoms from the urinary tract without bacteriuria—in particular urethritis—were found to predominate. In middle-aged women, the urinary tract symptoms were ascribed increasingly to genital prolapse, while incidence of urolithiasis was the highest in any group, and urinary tract infections became less frequent. The prevalence of urinary tract infection showed another increase in elderly women, and recurrent/chronic pyelonephritis, which occurs with a steadily increasing prevalence throughout all age groups, became common.
In younger male urological patients diseases with symptoms of urinary tract infection without bacteriuria were predominant, whereas prostatitis and urinary tract infections were less frequent. In middle-aged men, urolithiasis was especially frequent, while an increasing proportion of elderly men had prostatic hypertrophy, urinary tract infections, and recurrent/chronic pyelonephritis.
PMCID: PMC1629787  PMID: 4187693
25.  Chlamydia (uncomplicated, genital) 
BMJ Clinical Evidence  2010;2010:1607.
Introduction
Genital chlamydia is the most commonly reported bacterial sexually transmitted infection (STI) in developed countries. In women, infection occurs most commonly between the ages of 16 and 19 years.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of antibiotic treatment for men and non-pregnant women with uncomplicated genital chlamydial infection?What are the effects of antibiotic treatment for pregnant women with uncomplicated genital chlamydial infection? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 24 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: amoxicillin, ampicillin, azithromycin, ciprofloxacin, clarithromycin, clindamycin, doxycycline, erythromycin, lymecycline, minocycline, ofloxacin, pivampicillin, rifampicin, roxithromycin, sparfloxacin, tetracycline, and trovafloxacin.
Key Points
Genital chlamydia (Chlamydia trachomatis serotypes D–K) is a sexually transmitted infection (STI) that infects the urethra in men and the endocervix or urethra (or both) in women. It is defined as uncomplicated if it has not ascended to the upper genital tract or caused sexually acquired reactive arthritis. It is the most common bacterial STI in developed countries. Over 200,000 chlamydia diagnoses were made in the UK in 2008, with 60% of cases being detected in departments of genitourinary medicine.Infection is usually asymptomatic, particularly in women. Most people infected do not present for testing or treatment. Therefore, population rates based on routine surveillance data underestimate the true disease burden. One in 14 men and one in 11 women aged under 25 years screened as part of the National Chlamydia Screening Programme in the UK tested positive for chlamydia. If untreated, chlamydial infection can ascend to the upper genital tract, causing pelvic inflammatory disease (PID), which may result in infertility, ectopic pregnancy, or chronic pelvic pain.Partner notification and treatment is an important part of effective management.Chlamydia-positive individuals are at high risk of retesting positive within 1 year. There is a growing body of opinion that repeat testing at 3 to 12 months after treatment, or sooner if there is a change of sexual partner, is likely to be beneficial for public health.
Multiple-dose regimens of tetracyclines (doxycycline or tetracycline) achieve microbiological cure in at least 95% of men and non-pregnant women with genital chlamydia. Erythromycin also seems beneficial as a multiple-dose regimen, but we don't know which regimen of erythromycin is more effective. Ciprofloxacin seems less likely to lead to microbiological cure compared with doxycycline.We don't know whether multiple-dose regimens of other antibiotics (such as other macrolides, quinolones, and penicillins) are effective, as we found few adequate studies.
A single dose of azithromycin seems as beneficial as a 7-day course of doxycycline, and produces similar rates of adverse effects. Single-dose treatments have the obvious advantage of improving adherence.Treatment cure rates of over 95% have been reported, and a test of cure is only considered necessary if non-compliance or re-exposure is suspected.
In pregnant women, multiple-dose regimens of erythromycin or amoxicillin seem effective in treating chlamydial infection. One small study has also suggested that clindamycin and multiple-dose erythromycin are equally effective at curing infection, although the size of the study makes it hard to draw definitive conclusions.
Single-dose azithromycin may be effective in treating chlamydia in pregnant women. However, it should be used only if no adequate alternative is available.
In pregnant women, no antibiotic regimen has a microbiological cure rate of over 95%, and pregnant women should be offered a test of cure no sooner than 5 weeks after treatment was initiated to ensure that the infection has cleared.
PMCID: PMC2907609  PMID: 21718568

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