CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Cefiderocol +2 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/NCT03032380
NCT03032380Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens

Shionogi·interventional·Posted Jan 26, 2017·Updated Nov 13, 2020

In Brief

A Phase 3 clinical trial evaluating Cefiderocol, Meropenem, and 1 other intervention for Healthcare-associated Pneumonia (HCAP) and 2 related conditions. Completed, enrolled 300 participants across 119 sites in 19 countries.

Detailed Summary

The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP), Ventilator Associated Pneumonia (VAP)
CountriesBelgium, Canada, Czechia, Estonia, France, Georgia, Germany, Hungary, Israel, Japan, Latvia, Philippines, Puerto Rico, Russia, Serbia, Spain, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 26, 2017
Enrollment StartOct 24, 2017
Primary CompletionFeb 26, 2019
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.4 years ago

Interventions

Cefiderocoldrug

2000 mg intravenously every 8 hours for a period of 7 to14 days (dosage adjustment is necessary based on renal function)

Meropenemdrug

2000 mg intravenously every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function)

Linezoliddrug

600 mg of linezolid administered intravenously over 30 minutes to 2 hours, every 12 hours.