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

Sponsor
Sichuan Provincial People's Hospital
Study ID
NCT07601711
Status
Recruiting
Apply to this trial

Conditions

  • Bloodstream Infection
  • Carbapenem-Resistant Acinetobacter Baumannii Infection
  • Pneumonia
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Nov 11, 2025
Status verified
May 2026
Primary completion
Nov 11, 2027
Completion
Nov 11, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Sulbactam-Durlobactam Group
    Patients receiving sulbactam-durlobactam within 48 hours after treatment initiation.
  • Arm: Non-Sulbactam-Durlobactam Group
    Patients receiving alternative anti-CRAB regimens during the same period without sulbactam-durlobactam.

Primary Outcome Measure

28-day All-Cause Mortality [ Time Frame: Up to 28 days after initiation of anti-CRAB therapy ]

Related Studies