2519. A Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects with Hospital-Acquired Bacterial Pneumonia or Ventilator-Assoc
Abstract
Abstract Background Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are associated with high mortality rates. In these patients, there is an unmet need for effective antimicrobial therapy. This study enrolled participants mainly from China to support the regional use of imipenem/cilastatin/relebactam (IMI/REL). The aim of the study was to assess the efficacy and safety of IMI/REL compared with piperacillin/tazobactam (PIP/TAZ) for the treatment of HABP/VABP. Methods This study was a Phase 3, randomized trial conducted in 8 countries (NCT03583333). Participants 18–90 years of age with HABP/VABP requiring intravenous (IV) antibiotic treatment were randomized 1:1 to receive either IV IMI/REL (500 mg IMI/250 mg REL) or PIP/TAZ (4000 mg/500 mg) administered every 6 h for 7–14 days. The primary endpoint was day 28 all-cause mortality in the modified intent-to-treat (MITT) population (excluding patients with only gram-positive cocci at baseline). Secondary endpoints included clinical response rate, microbiological response rate and adverse events (AEs). Results In total, 270 patients (IMI/REL, N=134; PIP/TAZ, N=136) were included in the MITT population, with 201 patients from mainland China (IMI/REL, N=106; PIP/TAZ, N=100). Demographics and baseline characteristics were generally comparable for both treatment groups in the MITT population, with the exception of preexisting cerebrovascular conditions which were higher in IMI/REL vs…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 270 participants or records.
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