MedTrace Logo

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

NCT03032380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-11-13

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2019-02-26
Completion
2019-04-01
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Estonia
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Japan
  • Latvia
  • Philippines
  • Puerto Rico
  • Russia
  • Serbia
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03032380 on ClinicalTrials.gov