CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 271 enrolled
Drug / intervention
ertapenem sodium (MK0826) +1 moredrug
Likely dose
ertapenem sodium (MK0826) 1.0gfrom 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/NCT01014013
NCT01014013Phase 3Completed

A Prospective, Multicenter, Partially-Blinded, Randomized, Comparative Study to Evaluate the Safety, Tolerability and Efficacy of INVANZ Versus Ceftriaxone Sodium in the Treatment of Complicated Urinary Tract Infections in Adults

Merck Sharp & Dohme LLC·interventional·Posted Nov 16, 2009·Updated Mar 22, 2017

In Brief

A Phase 3 clinical trial evaluating ertapenem sodium (MK0826) and Comparator: ceftriaxone sodium for Urinary Tract Infection. Completed, enrolled 271 participants.

Detailed Summary

The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 16, 2009
Enrollment StartApr 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.6 years ago

Interventions

ertapenem sodium (MK0826)drug

a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed)

Comparator: ceftriaxone sodiumdrug

a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy)