NCT05922124

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

Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 734 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be a prospective controlled clinical study with historical controls. In the prospective CASCADE study consecutive consenting patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia will be treated with cefiderocol combined with ampicillin sulbactam in 3 hospitals in Israel and 2 hospitals in Italy, all endemic for CRAB. We plan to recruit 150 patients into this prospective studies. The CASCADE cohort will be compared to patients treated for the same types of infection in two recently completed randomized controlled trials (AIDA and OVERCOME). These trials compared between treatment with colistin vs. treatment with colistin-meropenem combination therapy, both finding no difference between treatment groups among patients with carbapenem-resistant Acinetobacter baumannii (CRAB) pneumonia. Thus, patients in CASCADE will be compared to all patients with CRAB bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia in these randomized controlled trials.

Conditions

• Carbapenem Resistant Bacterial Infection
• Acinetobacter Bacteremia
• Acinetobacter Pneumonia

Interventions

Type	Name	Description
DRUG	Cefiderocol	Test drug regimen
DRUG	Ampicillin-sulbactam	Synergistic combination
DRUG	Colistin	Historical comparator
DRUG	Meropenem	Historical comparator synergistic combination

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2023-06-28
• Last updated: 2025-08-01

Locations

3 sites across 1 country: Israel

Regulatory

• FDA-regulated drug study