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

Recruitingn/aAges 18 Years - anyAllSichuan Provincial People's Hospital
NCT07601711 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Sulbactam-Durlobactam
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Where

1 site
Sichuan Provincial People's Hospital
Chengdu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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