The primary efficacy endpoint for patients with cIAI was clinical response at end of treatment (EOT) in the microbiologically evaluable (ME) population, and for patients with cUTI was microbiological response at EOT in the ME population. 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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