About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
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.
Disqualifiers
Colonization without evidence of active infection.
Missing key clinical data.
Inability to determine treatment initiation time.
Pregnancy or lactation.
Trial population
Hospitalized adult patients receiving anti-CRAB antimicrobial therapy in real-world clinical practice, including: 1. patients with confirmed carbapenem-resistant Acinetobacter baumannii (CRAB) infection; or 2. transplant recipients with donor-derived CRAB colonization or infection receiving early targeted therapy.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Sulbactam-Durlobactam
DrugSulbactam-durlobactam administered according to routine clinical practice for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB) infection.
Treatment groups
Trial outcomes
Primary outcomes
28-day All-Cause Mortality
All-cause mortality occurring within 28 days after initiation of anti-CRAB therapy.
Secondary outcomes
Clinical Failure
Clinical failure defined as lack of clinical improvement, need for escalation of antimicrobial therapy, or death.
Length of ICU stay
Duration of ICU stay measured from ICU admission to ICU discharge.
Time to clinical improvement
Time from initiation of anti-CRAB therapy to predefined clinical improvement.
Microbiological eradication
Microbiological eradication confirmed by follow-up culture negativity.
Sponsors and contacts
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