At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 60 enrolled

Drug / intervention

PF-06947386 +1 moredrug

Likely dose

PF-06947386 2.0 gfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04927312

NCT04927312Phase 3Completed

Compare CT.gov

A PHASE 3, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (PF-06947386) PLUS METRONIDAZOLE IN JAPANESE ADULT PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTION REQUIRING HOSPITALIZATION

Pfizer·interventional·Posted Jun 15, 2021·Updated Mar 13, 2024

In Brief

A Phase 3 clinical trial evaluating PF-06947386 and Metronidazole for Complicated Intra-abdominal Infection. Completed, enrolled 60 participants across 29 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsComplicated Intra-abdominal Infection

CountriesJapan

Collaborators--

Timeline

Phase 3CompletedFinished

20222023202420252026

First PostedJun 2021

Enrollment StartOct 2021

Primary CompletionSep 2022

TodayJul 2026

First PostedJun 15, 2021

Enrollment StartOct 1, 2021

Primary CompletionSep 15, 2022

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 5.0 years ago

Interventions

PF-06947386drug

Ceftazidime-Avibactam powder for concentrate for solution for infusion 2.0 g/ 0.5 g. Dosage will be adjusted based on renal function after enrollment.

Metronidazoledrug

Metronidazole 0.5 g solution for injection.