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

NCT07226557 | Active Not Recruiting

• 1 other identifier: BD070725
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Carbapenem-resistant Acinetobacter baumannii; Cefiderocol; Target trial emulation

Outcome Measures

Primary Outcomes (1)

• Mortality

  In hospital mortality or discharge to hospice during the hospital stay

  During inpatient admission

Secondary Outcomes (3)

• Length of Stay

  Inpatient admission

• Recurrent CRAB Infection

  Within 30 days post discharge

• Development of antibiotic resistance to initial antibiotic treatment

  Subsequent admissions

Study Arms (2)

Reciept of cefiderocol

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

Reciept of best available therapy (BAT)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adult patients with a clinical culture positive for carbapenem resistant A. baumannii and received an antibiotic with possible in vitro activity against carbapenem resistant A. baumannii in the time frame of interest (i.e., days before culture collection until 2 days after first available antibiotic susceptibility test result was made available) and admitted to US hospitals reporting to the PINC-AI healthcare database between 2018-2024 will be eligible for inclusion in the hypothetical target trials.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Study Officials

• Sameer Kadri, MD

  National Institutes of Health CC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 10, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)