CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 38 enrolled
Drug / intervention
Metronidazole +1 moredrug
Likely dose
Metronidazole 500 mgfrom 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/NCT01473836
NCT01473836Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Unblind, Non-Comparative Study To Confirm Efficacy And Safety Of Intravenous Metronidazole In Patients With Intrabdominal Infection In Combination With Intravenous Ceftriaxone

Pfizer·interventional·Posted Nov 17, 2011·Updated Jan 24, 2014

In Brief

A Phase 3 clinical trial evaluating Metronidazole and Ceftriaxone sodium for Intra-abdominal Infections. Completed, enrolled 38 participants across 15 sites.

Detailed Summary

The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntra-abdominal Infections
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2011
Enrollment StartNov 1, 2011
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.6 years ago

Interventions

Metronidazoledrug

Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition.

Ceftriaxone sodiumdrug

Ceftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID.