CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 152 enrolled
Drug / intervention
Cefiderocol +1 moredrug
Likely dose
Cefiderocol 2 gfrom 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/NCT02714595
NCT02714595Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

Shionogi·interventional·Posted Mar 21, 2016·Updated Jan 12, 2021

In Brief

A Phase 3 clinical trial evaluating Cefiderocol and Best Available Therapy for Healthcare-associated Pneumonia (HCAP) and 5 related conditions. Completed, enrolled 152 participants across 85 sites in 16 countries.

Detailed Summary

This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI), Sepsis, Ventilator Associated Pneumonia (VAP)
CountriesBrazil, Croatia, France, Germany, Greece, Guatemala, Israel, Italy, Japan, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 21, 2016
Enrollment StartSep 7, 2016
Primary CompletionApr 1, 2019
Study CompletionApr 22, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.3 years ago

Interventions

Cefiderocoldrug

2 g intravenously over 3 hours every 8 hours for a period of 7 to 14 days, or 2 g every 6 hours for participants with creatinine clearance \>120 mL/min.

Best Available Therapydrug

Standard of care with either a polymyxin-based or non-polymyxin-based regimen as determined by the investigator and consisting of one to three marketed antibacterial agent(s).