NCT03032380

Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Healthcare-associated Pneumonia (HCAP)
• Hospital Acquired Pneumonia (HAP)
• Ventilator Associated Pneumonia (VAP)

Interventions

Type	Name	Description
DRUG	Cefiderocol	2000 mg intravenously every 8 hours for a period of 7 to14 days (dosage adjustment is necessary based on renal function)
DRUG	Meropenem	2000 mg intravenously every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function)
DRUG	Linezolid	600 mg of linezolid administered intravenously over 30 minutes to 2 hours, every 12 hours.

Timeline

• Start date: 2017-10-24
• Primary completion: 2019-02-26
• Completion: 2019-04-01
• First posted: 2017-01-26
• Last updated: 2020-11-13
• Results posted: 2020-11-13

Locations

119 sites across 19 countries: United States, Belgium, Canada, Czechia, Estonia, France, Georgia, Germany, Hungary, Israel, Japan, Latvia, Philippines, Puerto Rico, Russia, Serbia, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study