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

Recruiting now

Conditions studied: Carbapenem-Resistant Acinetobacter Baumannii Infection, Bloodstream Infection, Pneumonia, Sepsis

In brief

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 facts

Study ID

NCT07601711

Run by

Sichuan Provincial People's Hospital

People needed

200

Starts

2025-11-11

Expected to finish

2027-11-11

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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