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

NCT07601711 · tracked via the Priya Life Science China tracker

Sponsor

Sichuan Provincial People's Hospital

Phase

Observational

Started

2025-11-11

Last updated

2026-05-22

Condition(s) studied

Carbapenem-Resistant Acinetobacter Baumannii InfectionBloodstream InfectionPneumoniaSepsis

Investigational drug(s) / intervention(s)

Sulbactam-Durlobactam

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥18 years. * Hospitalized patients receiving anti-CRAB antimicrobial therapy, including: 1. patients with confirmed carbapenem-resistant Acinetobacter baumannii (CRAB) infection based on microbiological testing in combination with clinical evidence of infection; or 2. 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 Criteria: * Colonization without evidence of active infection. * Missing key clinical data. * Inability to determine treatment initiation time. * Pregnancy or lactation. * Patients considered unsuitable by investigators.

Primary outcome measure(s)

28-day All-Cause Mortality — Up to 28 days after initiation of anti-CRAB therapy
All-cause mortality occurring within 28 days after initiation of anti-CRAB therapy.

Trial sites (1)

Facility	City	Region	Status
Sichuan Provincial People's Hospital	Chengdu	Sichuan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07601711 on ClinicalTrials.gov ↗ ← All trials in China