CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 470 enrolled
Drug / intervention
Tigecycline +1 moredrug
Likely dose
Tigecycline 100 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/NCT01721408
NCT01721408Phase 4Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Comparison Study Of The Efficacy And Safety Of Tigecycline To Imipenem/Cilastatin To Treat Complicated Intra-abdominal Infections In Hospitalized Subjects.

Pfizer·interventional·Posted Nov 5, 2012·Updated Apr 9, 2018

In Brief

A Phase 4 clinical trial evaluating Tigecycline and Imipenem/cilastatin for Intra-abdominal Infection. Completed, enrolled 470 participants across 47 sites.

Detailed Summary

This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntra-abdominal Infection
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 5, 2012
Enrollment StartNov 1, 2012
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.7 years ago

Interventions

Tigecyclinedrug

every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.

Imipenem/cilastatindrug

every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.