Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation

National Institutes of Health Clinical Center (CC)

Status: Active, not recruiting

Conditions: Antimicrobial Drug Resistance; Acinetobacter Baumannii Infection; Carbapenem Resistant Bacterial Infection

Study type: Observational

Funder types: NIH

Identifiers

NCT07226557

BD070725

Details and patient eligibility

About

This study aims to compare 28-day mortality among patients with carbapenem resistant A. baumannii infections in two hypothetical target trials where patients receive 7 days of a cefiderocol-based treatment strategy or 7 days of a best available therapy treatment strategy.

Full description

please see uploaded study protocol

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized adults (≥ 18 years of age)
• Carbapenem resistant A. baumannii-calcoaceticus complex clinical culture
• Antimicrobial agent with possible in vitro activity against carbapenem resistant A. baumannii-calcoaceticus complex initiated in the time frame of 2 days before culture collection until 2 days following first available antibiotic susceptibility test result being made available

Exclusion criteria

• Patients with no antibiotic susceptibility testing
• Patients with only A. baumannii infection diagnosed by rapid diagnostic tests (i.e., multiplex polymerase chain reaction)
• Initiation of antimicrobial agent outside of selected time frame (i.e., 2 days before culture collection until 2 days after first available antibiotic susceptibility test result was made available)

Trial design

5,000 participants in 2 patient groups

Reciept of cefiderocol

Description:

Inpatients with carbapenem-resistant Acinetobacter baumannii infection that receive empiric and/or targeted therapy including cefiderocol.

Reciept of best available therapy (BAT)

Description:

Inpatients with carbapenem-resistant Acinetobacter baumannii infection that receive empiric and/or targeted therapy with activity against the infection but does not include cefiderocol