Multicenter Validation of a Risk Prediction Model for MDRGNB Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study
Overview
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.
Primary outcome measures
- MDRGNB infection [Time frame: 48 hours after ICU admission]
Secondary outcome measures (3)
- 28-day mortality [Time frame: 28 day after ICU admission]
- Sequential Organ Failure Assessment (SOFA) score at 48 hours [Time frame: 48 hours after ICU admission]
- Adverse events related to antibiotic within 28 days [Time frame: 28 day after admission]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 11 centers
- Nanjing Drum Tower Hospital — Nanjing
- Ankang People's Hospital — Ankang
- Sinopharm Tongmei General Hospital — Datong
- First Affiliated Hospital of Gannan Medical University — Ganzhou
- Zhejiang Hospital — Hangzhou
- Zhejiang Provincial People's Hospital — Hangzhou
- Huaian First People's Hospital — Huaian
- Guangxi Provincial Tumor Hospital — Nanning
- … and 3 more centers
Identifiers
NCT: NCT07603128 · 2026-0453-02