NCT07603128RecruitingNot Applicable
Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School11 sites in 1 country1,000 target enrollmentStarted: May 22, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 11
Study Overview
Brief Summary
This prospective multicenter validation study aimed to evaluate the predictive performance of a previously developed model for MDRGNB infection in ICU patients.
Detailed Description
Adult ICU patients were prospectively and consecutively enrolled across 11 research centers. MDRGNB infection risk predictions were generated within 24 hours of ICU admission using routinely available clinical data. Without interfering with clinical decision-making, the study assessed the discrimination, calibration, and clinical net benefit of the previously developed MDRGNB infection risk prediction model in real-world practice, applying the predefined threshold of 0.318.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years;
- •ICU stay ≥48 hours;
- •At least one clinical microbiological specimen collected and submitted for testing within 48 hours of ICU admission, with the first submission time designated as the index time;
- •Core predictive variables of the model extractable from electronic medical records or laboratory information systems.
Exclusion Criteria
- •For patients with multiple ICU admissions, only the first ICU stay was retained;
- •Missing or indeterminate primary outcome;
- •Missing key predictive variables that could not be handled according to prespecified rules.
Investigators
Chen Dayu
Pharmacist in Charge
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sites (11)
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