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Active, Not Recruiting

NCT Number: NCT07226557

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Carbapenem Resistant Bacterial Infection Acinetobacter Baumannii Infection Antimicrobial Drug Resistance

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

please see uploaded study protocol

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: During inpatient admission

    In hospital mortality or discharge to hospice during the hospital stay

Secondary outcomes

  1. Length of Stay

    Time frame: Inpatient admission

    Duration of hospitalization among surviving patients

  2. Recurrent CRAB Infection

    Time frame: 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.

  3. Development of antibiotic resistance to initial antibiotic treatment

    Time frame: Subsequent admissions

    Development of antibiotic resistance on a subsequent positive clinical culture to an antibiotic administered during prior infectious episode

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 10, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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