Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorRambam Health Care Campus
About this trial
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 criteria
Qualifiers
None
Disqualifiers
More than 72 hours of therapy with in-vitro coverage against the CRAB within 96 hours of enrolment
Polymicrobial carbapenem-susceptible infections: growth of other pathogens susceptible to carbapenems, or another beta-lactam, deemed clinically-significant by the treating physicians in blood or sputum (with HAP/ VAP). We will allow recruitment of patients with other carbapenem-resistant Gram-negative bacteria
CRAB susceptible any beta-lactam other than cefiderocol
Coronavirus 2019 (COVID-19) co-infection
Trial design
Treatments tested in this trial
- Cefiderocol
- Ampicillin-sulbactam
- Colistin
- Meropenem
Treatment groups
734 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rambam Health Care Campus
Lead sponsor
Monaldi Hospital
Collaborator
Rutgers Robert Wood Johnson Medical School
Collaborator
Pisa University Hospital
Collaborator
Assaf-Harofeh Medical Center
Collaborator
Sheba Medical Center
Collaborator
Source ClinicalTrials.gov