At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 122 enrolled

Drug / intervention

CXA-101/ tazobactam and metronidazole +1 moredrug

Likely dose

CXA-101/ tazobactam and 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/NCT01147640

NCT01147640Phase 2Completed

Compare CT.gov

A Multicenter, Double-Blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA 101/ Tazobactam and Metronidazole With That of Meropenem in Complicated Intraabdominal Infections

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Jun 22, 2010·Updated Oct 25, 2018

In Brief

A Phase 2 clinical trial evaluating CXA-101/ tazobactam and metronidazole and meropenem plus saline placebo for Complicated Intra-abdominal Infection. Completed, enrolled 122 participants across 33 sites in 5 countries.

Detailed Summary

A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000 mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose adjustments for subjects with mild renal impairment are not necessary and subjects with more severe degrees of renal failure are excluded.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsComplicated Intra-abdominal Infection

CountriesArgentina, Georgia, Russia, Serbia, United States

Collaborators--

Timeline

Phase 2CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

First PostedJun 2010

Enrollment StartJun 2010

Primary CompletionFeb 2011

Study CompletionMar 2011

TodayJul 2026

First PostedJun 22, 2010

Enrollment StartJun 25, 2010

Primary CompletionFeb 20, 2011

Study CompletionMar 25, 2011

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 16.0 years ago

Interventions

CXA-101/ tazobactam and metronidazoledrug

CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion

meropenem plus saline placebodrug

meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion