CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 452 enrolled
Drug / intervention
Cefiderocol +1 moredrug
Likely dose
Cefiderocol 2000 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/NCT02321800
NCT02321800Phase 2Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections With or Without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-Negative Pathogens in Hospitalized Adults in Comparison With Intravenous Imipenem/Cilastatin

Shionogi·interventional·Posted Dec 22, 2014·Updated Dec 12, 2019

In Brief

A Phase 2 clinical trial evaluating Cefiderocol and Imipenem/cilastatin for Urinary Tract Infections. Completed, enrolled 452 participants.

Detailed Summary

The purpose of this study was to determine the efficacy and safety of intravenous cefiderocol (S-649266) in hospitalized adults with complicated urinary tract infections caused by Gram-negative pathogens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infections
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 22, 2014
Enrollment StartFeb 5, 2015
Primary CompletionJul 26, 2016
Study CompletionAug 16, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.5 years ago

Interventions

Cefiderocoldrug

2000 mg intravenously every 8 hours for 7 to 14 days; dose adjustments for participants with reduced renal function (estimated CrCl ≤ 70 mL/minute) and/or body weight (\< 70 kg) included every 6-hour dosing intervals and/or reduced doses.

Imipenem/cilastatindrug

1000 mg of each intravenously every 8 hours for 7 to 14 days; dose adjustments for participants with reduced renal function (estimated CrCl ≤ 70 mL/minute) and/or body weight (\< 70 kg) included every 6-hour dosing intervals and/or reduced doses.