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This is a Single-center Real-world Observational Cohort Study of Sulbactam-Durlobactam for Carbapenem-Resistant Acinetobacter Baumannii Infections: Effectiveness, Safety, and Exposure-Response Analysis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2027-11-11
Participants
Target number of participants: 200
Treatments
Sulbactam-Durlobactam Group
Patients receiving sulbactam-durlobactam within 48 hours after treatment initiation.
Non-Sulbactam-Durlobactam Group
Patients receiving alternative anti-CRAB regimens during the same period without sulbactam-durlobactam.
Related Therapeutic Areas
Sponsors
Leads: Sichuan Provincial People's Hospital

This content was sourced from clinicaltrials.gov