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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

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