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Pneumonia is a leading cause of death associated with hospital-acquired infections. Late ventilator-associated pneumonia (VAP), defined as disease onset after ≥4 days of mechanical ventilation, is associated with worse outcomes than other forms of hospital-acquired pneumonia (HAP).
ATTAIN 1 and 2 were methodologically identical, randomized, phase 3 studies of telavancin (TLV) 10 mg/kg intravenously every 24 hours vs vancomycin (VAN) 1 g intravenously every 12 hours for treatment of HAP, including VAP. VAN doses could be adjusted per investigative site guidelines. Clinical outcome was assessed at the test-of-cure (TOC) visit 7 to 14 days after the end of study treatment. Baseline characteristics, outcomes, and safety in the late VAP sub-group were analyzed in the modified all-treated population (MAT; patients with baseline respiratory pathogen(s) who received ≥1 dose of study medication) and the microbiologically evaluable population (ME; protocol adherent MAT patients with baseline Gram-positive pathogen(s)). Patients with mixed Gram-positive/Gram-negative infections were excluded in this analysis.
A total of 197 late VAP cases were analyzed. Baseline characteristics, including the APACHE II scores, were balanced between the treatment groups (Figure (Figure1).1). At least one adverse event (AE) was reported by 95% (106/112) and 93% (79/85) of MAT patients in the TLV and VAN groups, respectively, and 21% (23/112) of the TLV group and 22% (19/85) of the VAN group died during the study.
In this exploratory sub-group analysis, numerically higher cure rates were observed for TLV than for VAN in patients with late VAP. Incidences of reported AEs and mortality rates were similar between the TLV and VAN groups.