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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07226557

Enrollment

5000

Registered

2025-11-10

Start date

2025-01-01

Completion date

2025-12-31

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Carbapenem-resistant Acinetobacter baumannii, Cefiderocol, Target trial emulation

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Mortality	During inpatient admission	In hospital mortality or discharge to hospice during the hospital stay

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results