RecruitingNCT07601711

Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study

This is a Single-center Real-world Observational Cohort Study of Sulbactam-Durlobactam for Carbapenem-Resistant Acinetobacter Baumannii Infections: Effectiveness, Safety, and Exposure-Response Analysis


Sponsor

Sichuan Provincial People's Hospital

Enrollment

200 participants

Start Date

Nov 11, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This is a multicenter real-world observational cohort study designed to evaluate the effectiveness and safety of sulbactam-durlobactam in patients with carbapenem-resistant Acinetobacter baumannii (CRAB) infections. Patients receiving sulbactam-durlobactam will be compared with those receiving other anti-CRAB regimens during the same period. The primary outcomes are 28-day all-cause mortality and clinical failure. Secondary outcomes include microbiological clearance, recurrence, length of hospital and ICU stay, duration of mechanical ventilation, and adverse events. To reduce confounding inherent in observational studies, propensity score methods, including matching and inverse probability weighting, will be applied. A nested therapeutic drug monitoring (TDM) sub-cohort will be established to explore the relationship between drug exposure and clinical outcomes.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Age ≥18 years.
  • Hospitalized patients receiving anti-CRAB antimicrobial therapy, including:
  • patients with confirmed carbapenem-resistant Acinetobacter baumannii (CRAB) infection based on microbiological testing in combination with clinical evidence of infection; or
  • transplant recipients with donor-derived CRAB colonization or infection who receive early targeted antimicrobial therapy.
  • Treatment initiation time can be clearly determined.
  • Availability of clinical outcome data.

Exclusion Criteria5

  • Colonization without evidence of active infection.
  • Missing key clinical data.
  • Inability to determine treatment initiation time.
  • Pregnancy or lactation.
  • Patients considered unsuitable by investigators.

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Interventions

DRUGSulbactam-Durlobactam

Sulbactam-durlobactam administered according to routine clinical practice for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB) infection.


Locations(1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

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NCT07601711


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