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)

What this Trial Is About

Researchers are evaluating treatment options for patients with bloodstream infections, hospital-acquired pneumonia, or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB). The study compares a combination of cefiderocol and ampicillin-sulbactam to treatments involving colistin alone or colistin combined with meropenem. This prospective controlled clinical study uses historical controls from previous randomized trials to assess these treatments in real-world hospital settings in Israel and Italy. The study involves two treatment groups: one receiving cefiderocol 2 grams intravenously every 8 hours plus ampicillin-sulbactam 3 grams intravenously every 6 hours, both given as extended infusions over 3 hours. Dosages are adjusted based on kidney function and renal replacement therapies. The comparison group consists of patients treated with a colistin loading dose of 9 million units intravenously followed by 4.5 million units, with or without meropenem 2 grams intravenously as an extended infusion. The study plans to recruit 150 patients and compare outcomes with historical data from earlier trials. Participants will be monitored for outcomes including all-cause mortality at 28 days, clinical and microbiological failure, resistance development, hospital stay length, functional capacity decline, and adverse events such as Clostridiodes difficile infection, kidney failure, and liver injury. Assessments occur at multiple time points up to 28 days. The study follows patients closely during treatment and tracks safety and effectiveness measures to better understand treatment impacts for these serious infections.

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