Sulbactam-Durlobactam for CRAB infections in real-world care
Official title: 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
Run by Sichuan Provincial People's Hospital · NCT07601711 · Data updated 2026-11-12
This real-world study tests whether sulbactam-durlobactam works and is safe for adults with carbapenem-resistant Acinetobacter baumannii infections, compared with other anti-CRAB treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Status | Recruiting |
| Started | November 11, 2025 |
| Main results expected | November 11, 2027 |
| Study ends | November 11, 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07601711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) hospitalized with confirmed CRAB infection or donor-derived CRAB infection in transplant recipients, who are treated with anti-CRAB therapy and for whom treatment start time and outcomes are available.
✕Probably not a fit
Patients with colonization without active infection or with missing essential data may not benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational cohort study analyzes adults hospitalized with CRAB infections to see how sulbactam-durlobactam performs in real clinical practice. Patients are grouped by whether they receive sulbactam-durlobactam or alternative anti-CRAB regimens during the same period. Primary outcomes include 28-day all-cause mortality and clinical failure, with secondary outcomes such as microbiological clearance, recurrence, ICU and hospital length of stay, duration of ventilation, and adverse events. To reduce bias, the study uses propensity score matching and inverse probability weighting, along with multivariable regression and landmark analysis. A nested TDM sub-cohort will examine drug exposure and outcomes using PK/PD modeling.
Why it matters
Potential benefit: If successful, the study could clarify the real-world effectiveness and safety of sulbactam-durlobactam for CRAB infections and help guide treatment decisions.
How similar studies have gone: Real-world observational studies have shown variable results for anti-CRAB therapies; this study adds contemporary exposure data and bias-adjustment methods to clarify effectiveness.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.