NCT07601711 Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study
| NCT ID | NCT07601711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sichuan Provincial People's Hospital |
| Condition | Carbapenem-Resistant Acinetobacter Baumannii Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-11-11 |
| Primary Completion | 2027-11-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-11-11 with a primary completion date of 2027-11-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT07601711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carbapenem-Resistant Acinetobacter Baumannii Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07601711 currently recruiting?
Yes, NCT07601711 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sichuan Provincial People's Hospital to inquire about joining.
Where is the NCT07601711 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07601711 clinical trial?
NCT07601711 is sponsored by Sichuan Provincial People's Hospital. The trial plans to enroll 200 participants.