Serious AEs occurred in nine patients, including one death, but none were considered treatment related. The most common AEs were diarrhea and nausea (8.6%). Adverse events (AEs) were reported in 74.1% (n = 60/81) of patients, and drug-related AEs occurred in 18.5% (n = 15/81).
Escherichia coli was the most common baseline pathogen isolated in both patients with cIAI and cUTI. Of 83 patients enrolled, 81 patients (cIAI, n = 37 cUTI, n = 44) received ≥1 dose of study treatment. Sepsis was defined as an infection-induced systemic inflammatory response syndrome, with a documented positive blood culture patients meeting these protocol-defined criteria were evaluated for efficacy against sepsis. This phase 3, multicenter, open-label, noncomparative study ( NCT03293485) evaluated relebactam/imipenem/cilastatin (250 mg/500 mg/500 mg) dosed every 6 h for 5-14 days in Japanese patients with complicated intra-abdominal infections (cIAIs) or complicated urinary tract infections (cUTIs), including those with secondary sepsis.
Relebactam, a novel class A/C β-lactamase inhibitor developed as a fixed-dose combination with imipenem/cilastatin, restores imipenem activity against imipenem-nonsusceptible gram-negative pathogens.
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