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1.  Imiquimod 3.75% Cream Applied Daily to Treat Anogenital Warts: Combined Results from Women in Two Randomized, Placebo-Controlled Studies 
Objective. To evaluate if new imiquimod formulations using a shorter treatment duration are safe and efficacious to treat anogenital warts. Methods. In two studies 534 women ≥12 years of age (mean 33.4) with 2–30 warts (mean 7.9) and total wart area ≥10 mm2 (mean 166.3) were randomized (1 : 2 : 2) to placebo (106), imiquimod 2.5% (212) or 3.75% (216) creams applied once daily until complete clearance or a maximum of 8 weeks. Results. For placebo, imiquimod 2.5% and 3.75%, respectively, complete clearance of all warts was achieved in 14.2%, 28.3%, and 36.6% of women (intent-to-treat, P = 0.008 imiquimod 2.5%, and P < 0.001 3.75% versus placebo). Mean changes in wart counts were −10.7%, −50.9%, and −63.5% (per-protocol, P < 0.001 each active versus placebo) and safety-related discontinuation rates 0.9%, 1.4%, and 2.3%. Conclusions. Imiquimod 3.75% applied daily for up to 8 weeks was well tolerated and superior to placebo in treating women with external anogenital warts.
PMCID: PMC3162968  PMID: 21876641
2.  Once Daily Valacyclovir for Reducing Viral Shedding in Subjects Newly Diagnosed with Genital Herpes 
Objective. Genital herpes (GH) recurrences and viral shedding are more frequent in the first year after initial HSV-2 infection. The objective of this study was to provide the first evaluation of valacyclovir 1 g once daily compared to placebo in reducing viral shedding in subjects newly diagnosed with GH. Methods. 70 subjects were randomized to receive valacyclovir 1 g daily or placebo in a crossover design for 60 days with a 7-day washout period. A daily swab of the genital/anal-rectal area was self-collected for HSV-2 detection by PCR. Subjects attended the clinic for routine study visits and GH recurrence visits. Treatment differences were assessed using a nonparametric crossover analysis. Results. 52 subjects had at least one PCR measurement in both treatment periods and comprised the primary efficacy population. Valacyclovir significantly reduced HSV-2 shedding during all days compared to placebo (mean 2.9% versus 13.5% of all days (P < .01), a 78% reduction). Valacyclovir significantly reduced subclinical HSV-2 shedding during all days compared to placebo (mean 2.4% versus 11.0% of all days (P < .01), a 78% reduction). However, 79% of subjects had no GH recurrences while receiving valacyclovir compared to 52% of subjects receiving placebo (P < .01). Conclusion. In this study, the frequency of total and subclinical HSV-2 shedding was greater than reported in earlier studies involving subjects with a history of symptomatic genital recurrences. Our study is the first to demonstrate a significant reduction in viral shedding with valacyclovir 1 g daily compared to placebo in a population of subjects newly diagnosed with HSV-2 infection.
PMCID: PMC2724712  PMID: 19680456
3.  Piperacillin/Tazobactam (ZOSYN) 
PMCID: PMC2364504  PMID: 18476104
4.  Preterm Labor and Maternal Hypoxia in Patients With Community-Acquired Pneumonia 
Objective: We sought to determine if preterm labor is associated with the degree of maternal hypoxia in pregnant women with community-acquired pneumonia but no other maternal diseases.
Methods: We retrospectively reviewed the medical records of all antepartum patients admitted with a diagnosis of community-acquired pneumonia to an inner-city university hospital between 1983 and 1987. Included in this review were only the patients with radiologically confirmed diagnose of pneumonia and documented arterial blood gases on room air at the time of admission, but no other maternal diseases.
Results: A total of 22 cases were identified. There was no maternal mortality, but there were 2 patients (9%) who developed respiratory failure requiring mechanical ventilation. Bacteremia with Streptococcus pneumoniae was documented in 1 patient (5%). Preterm labor complicated 5 cases (23%) and led to preterm delivery in 3 patients (14%). Terbutaline tocolysis was instituted in 3 patients, but was discontinued in 1 patient who was allowed to deliver because of her worsening condition. Preterm labor was associated with the WBC count on admission, usually > 18,000/mm3, but no statistically significant correlation with the severity of maternal hypoxia was noted. Five patients (23%) were incorrectly diagnosed at the time of admission, 4 with an initial diagnosis of pyelonephritis and 1 with an initial diagnosis of cholecystitis.
Conclusions: Community-acquired pneumonia in the antepartum period is responsible for significant maternal and fetal complications even in the absence of other maternal diseases. Preterm labor and delivery remain frequent, and tocolysis should be used cautiously. At the time of admission, the diagnosis may be difficult. The degree of maternal hypoxia on admission does not correlate with the presence of preterm labor.
PMCID: PMC2364494  PMID: 18476096
6.  Chlamydia trachomatis: Management in Pregnancy 
Chlamydia trachomatis is a sexually transmitted disease (STD) commonly diagnosed in pregnancy. C. trachomatis has been linked to several pregnancy complications including premature rupture of membranes (PROM), preterm labor and birth, low birth weight, intrauterine growth retardation, and postpartum endometritis. Infants born to mothers through an infected birth canal are at risk for acquiring C. trachomatis pneumonitis, conjunctivitis, and nasopharyngeal infection. The standard treatment of C. trachomatis in pregnancy is erythromycin. Recently, amoxicillin and clindamycin have been added as alternative regimens for those patients intolerant of erythromycin. This paper reviews the effectiveness and tolerance of the alternative regimens compared with erythromycin and the success of antepartum treatment of chlamydia in preventing the poor pregnancy outcome and neonatal morbidity associated with C. trachomatis.
PMCID: PMC2364418  PMID: 18476026
7.  In Vitro Susceptibility Testing of Clinical Isolates of Chlamydia trachomatis  
Penicillin class antibiotics have demonstrated varying degrees of in vivo and in vitro success when tested against Chlamydia trachomatis. The activity of ampicillin-sulbactam, an agent commonly utilized in the treatment of pelvic infections, was tested to ascertain if any antichlamydial activity is present. Up to six endocervical isolates of C. trachomatis were tested against each of five antibiotics including doxycycline, erythromycin, clindamycin, ampicillin/sulbactam, and sulbactam alone. McCoy cell monolayers were inoculated with high inclusion counts of 10,000–30,000 inclusion-forming units (IFU) per coverslip, and exposed to each antibiotic. Up to nine subsequent antibiotic free culture passes were performed to assess the viability of abnormal inclusions. Doxycycline, erythromycin, and clindamycin achieved 100% eradication of inclusions at concentrations of 4.0, 2.0, and 1.0 µg/mL. Exposure to ampicillin/sulbactam resulted in a greater than 99% reduction in the inclusion count at 32.0 µg/mL, while sulbactam by itself demonstrated considerably less activity. Abnormal inclusions were noted only in the ampicillin/sulbactam exposed cells, and these, plus all inclusions remaining following sublethal exposure to the other antibiotics, resulted in regrowth to control levels in subsequent passes. Doxycycline and erythromycin demonstrated excellent activity. Clindamycin and ampicillin/sulbactam also significantly reduced inclusion formation, and therefore may provide adequate C. trachomatis coverage in patients receiving these antibiotics for pelvic infections.
PMCID: PMC2364677  PMID: 18476205
8.  Evaluation of Infectious Disease Knowledge in Obstetrics and Gynecology and the Effects of Varying Durations of Training 
Objective: The amount, origin, and resources of infectious disease knowledge in the field ofobstetrics and gynecology were investigated. If this knowledge is lacking, the exact length of the specific infectious disease training during residency should be defined to meet the ever-increasing knowledge required in training.
Methods: A 50-question test was developed by one faculty member utilizing questions that incorporated the basic sciences of microbiology and pharmacology and clinical knowledge of infectious diseases in the area of obstetrics and gynecology. Multiple choice and matching questions were structured so as to ascertain the source of the knowledge, including medical school curriculum, recent journal articles, and clinical experience.
Results: The test was given yearly to all students and residents on the Obstetric and Gynecology Service over a period of 2 year's. The questions were the same for each group, but were reshuffled each exam period. Three hundred and seven tests were properly administered and recorded. There was no statistical improvement in any successive year’s scores unless specific infectious disease training occurred. Increasing improvement in scores was noted, with an increasing duration of infectious disease training specific for obstetrics and gynecology, beginning at 2 weeks (22% improvement), 4 weeks (30% improvement), and 6 weeks (31% improvement) (P = .05–.001). Basic science questions were most frequently answered correctly by medical students and early residents, while correctly answered clinical questions correlated with increasing clinical experience except in the area of ambulatory care.
Conclusions: The infectious disease knowledge of residents in obstetrics and gynecology can be improved with 4 weeks of intensive training. Re-exposure to basic science knowledge and improved training in ambulatory care in this resident group appear to be necessary. This test or similar tests can be helpful in defining areas of deficiencies and their possible remedies.
PMCID: PMC2364306  PMID: 18475330
9.  Presence of Chlamydia, Mycoplasma, Ureaplasma, and Other Bacteria in the Upper and Lower Genital Tracts of Fertile and Infertile Populations 
Objective: The genital mycoplasmas (Mycoplasma hominis and Ureaplasma urealyticum) and Chlamydia trachomatis have been implicated as possible etiologic factors in infertility. Their role in patients with infertility needs to be further defined.
Methods: Seventy-nine infertile patients underwent laparoscopy with cultures obtained for aerobic and anaerobic bacteria, Chlamydia, Mycoplasma, and Ureaplasma from the peritoneal fluid, fallopian tube, endometrium, and endocervix. Cultures for similar organisms were taken from the endocervix of 80 fertile women in their first trimester. Culture results were also compared according to ovulatory status and laparoscopic findings in the infertile group.
Results: There were no differences in the recovery of Ureaplasma (29% vs. 28%) or Chlamydia (4% vs. 0%) positive cervical cultures in the fertile and infertile groups, respectively. However, a significantly higher number of Mycoplasma positive cervical cultures (14% vs. 5%, P = 0.05) were found in the fertile group. Only two upper genital tract cultures were found to be positive (Ureaplasma).
Conclusions: Therefore, if these organisms play a role in infertility, they are present and eradicated prior to infertility work-up and thus do not supports the use of a routine trial of antibiotics prior to laparoscopy.
PMCID: PMC2364301  PMID: 18475323

Results 1-9 (9)