CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 609 enrolled
Drug / intervention
plazomicin +2 moredrug
Likely dose
Not stated in 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/NCT02486627
NCT02486627Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Meropenem Followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), Including Acute Pyelonephritis (AP), in Adults

Achaogen, Inc.·interventional·Posted Jul 1, 2015·Updated Aug 23, 2018

In Brief

A Phase 3 clinical trial evaluating plazomicin, meropenem, and 1 other intervention for Complicated Urinary Tract Infection and Acute Pyelonephritis. Completed, enrolled 609 participants.

Detailed Summary

This was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Urinary Tract Infection, Acute Pyelonephritis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 1, 2015
Enrollment StartJan 11, 2016
Primary CompletionSep 22, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.0 years ago

Interventions

plazomicindrug

meropenemdrug

levofloxacin (oral)drug