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

Active, not recruiting

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

• Registration Number: NCT07226557
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

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.

Detailed Description

please see uploaded study protocol

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-07
• Study First Submitted: 2025-11-05
• Study First Submitted QC: 2025-11-07
• Last Update Submitted: 2025-11-07
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	During inpatient admission	In hospital mortality or discharge to hospice during the hospital stay

Secondary Outcome Measures

Name	Time	Method
Length of Stay	Inpatient admission	Duration of hospitalization among surviving patients
Recurrent CRAB Infection	Within 30 days post discharge	clinical culture positive for carbapenem-resistant A. baumannii (CRAB) infection within the same encounter downstream of the index episode and within 30 days.
Development of antibiotic resistance to initial antibiotic treatment	Subsequent admissions	Development of antibiotic resistance on a subsequent positive clinical culture to an antibiotic administered during prior infectious episode

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States