Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection

Phase 3 Completed 60 enrolled Pfizer

NaSingle-groupOpen-labelTreatment

Summary

Study C3591036 is a Phase 3 study to assess the efficacy and safety of PF-06947386 in Japanese adult patients with complicated intra-abdominal infection requiring hospitalization. This is a multicenter, open-label, single-arm study. All eligible participants will receive intravenous infusion of PF-06947386 followed by intravenous infusion of metronidazole.

Timeline

Start: 2021-10-01
Primary completion: 2022-09-15
Completion: 2022-09-15

Outcome

Met primary endpoint

paper The proportion of patients with clinical cure at TOC was greater than the pre-defined threshold of 78.0 %. PMID 39710167 ↗

Publications

Mikamo H, Nakazuru Y, Tabuchi R, Suzuki M, Nagashima M, Tawadrous M, Wible M, Ohta M. Efficacy and safety of ceftazidime-avibactam in combination with metronidazole in Japanese patients with complicated intra-abdominal infection: A phase 3, multicentre, open-label study. J Infect Chemother. 2025 Mar;31(3):102598. doi: 10.1016/j.jiac.2024.102598. Epub 2024 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftazidime	Small molecule	2 g	Intravenous
Subject	Metronidazole	Small molecule	0.5 g	Intravenous
Subject	avibactam	Small molecule	0.5 g	Intravenous

Indications

No indication recorded.