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Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii

NCT05922124 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 734

Last updated 2025-08-01

No results posted yet for this study

Summary

Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.

Conditions

  • Carbapenem Resistant Bacterial Infection
  • Acinetobacter Bacteremia
  • Acinetobacter Pneumonia

Interventions

DRUG

Cefiderocol

Test drug regimen

DRUG

Ampicillin-sulbactam

Synergistic combination

DRUG

Colistin

Historical comparator

DRUG

Meropenem

Historical comparator synergistic combination

Sponsors & Collaborators

  • Monaldi Hospital

    collaborator OTHER

  • Rutgers Robert Wood Johnson Medical School

    collaborator OTHER

  • Pisa University Hospital

    collaborator UNKNOWN

  • Assaf-Harofeh Medical Center

    collaborator OTHER_GOV

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Marco Falcone · Pisa University Hospital

  • Dafna Yahav · Sheba Medical Center

  • Mical Paul · Rambam Health Care Campus

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-07-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • Israel

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 NCT05922124 on ClinicalTrials.gov