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
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• Adults \>18 years with bacteremia or hospital-acquired pneumonia (HAP)/ ventilator-associated pneumonia (VAP) (Table 3) caused by carbapenem-resistant A. baumannii (CRAB) (meropenem and/ or imipenem minimal inhibitory concentration (MIC) \>8 μg/mL) susceptible to cefiderocol (disc zone diameter \>=17 mm, corresponding to an MIC \<2 μg/mL). We will include CRAB regardless of colistin, ampicillin-sulbactam, minocycline, tigecycline, trimethoprim/sulfamethoxazole and/or aminoglycoside susceptibility of the isolate. Attribution of the HAP/ VAP to CRAB will be allowed with isolation of CRAB from any respiratory sample within 7 days prior to the clinical diagnosis of pneumonia.
Locations
Other Locations
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Sheba Tel HaShomer Medical Campus
RECRUITING
Ramat Gan
Shamir Medical Center (Assaf Harofeh)
RECRUITING
Tel Aviv
Contact Information
Primary
Mical Paul
paulm@technion.ac.il
0502062140
Backup
Marco Falcone
marco.falcone@unipi.it
Time Frame
Start Date:2024-09-01
Estimated Completion Date:2026-09
Participants
Target number of participants:734
Treatments
Experimental: Cefiderocol + ampicillin-sulbactam
Cefiderocol 2 gram intravenous (IV) q8 hours and ampicillin-sulbactam 3 gram IV q6 hours for patients with normal creatinine clearance, both administered as extended infusion of 3 hours. Dosing adjusted according to reduced and augmented renal clearance and to renal replacement therapies.
Active_comparator: Colistin or colistin + meropenem
Colistin 9 million units (MIU) intravenous (IV) loading dose followed by 4.5 MIU for patients with normal creatinine clearance +/- meropenem 2 gram IV administered as extended infusion of 3 hours. Dosing adjusted according to reduced and augmented renal clearance and to renal replacement therapies.
Collaborators: Assaf-Harofeh Medical Center, Sheba Medical Center, Pisa University Hospital, Rutgers Robert Wood Johnson Medical School, Monaldi Hospital