Validating a risk score for MDRGNB infection in ICU patients
Official title: Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study
Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT07603128 · Data updated 2026-11-12
This study tests whether a previously developed risk score can predict MDRGNB infection in adults admitted to ICUs across multiple centers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 11 sites (Nanjing, Jiangsu and 10 other locations) |
| Status | Recruiting |
| Started | May 22, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT07603128 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) admitted to an ICU, expected ICU stay ≥48 hours, with microbiology testing within 48 hours of admission and extractable model variables from electronic records.
✕Probably not a fit
Patients whose data do not meet the model's required variables or whose infection risk is not better predicted by the model may not benefit from its use.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective multicenter study enrolls adult ICU patients from 11 centers to validate a risk prediction model for MDRGNB infection using data available within 24 hours of ICU admission. Predictions are generated from routine clinical data without altering patient care, and the study analyzes discrimination, calibration, and net benefit at a predefined threshold. The primary goal is to see how well the model predicts infection risk in real-world ICU settings and to determine its potential clinical usefulness. Eligible participants are adults 18 or older with ICU stays of at least 48 hours and available microbiology data, with key variables extractable from electronic records.
Why it matters
Potential benefit: If successful, the model could help clinicians identify high-risk patients early and guide targeted infection prevention or management strategies.
How similar studies have gone: Other studies of similar risk-prediction approaches in ICU infections have shown varying predictive performance, with some validation efforts demonstrating useful discrimination and calibration in real-world settings.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China Recruiting -
Zhejiang Hospital
Hangzhou, China Recruiting -
Guangxi Provincial Tumor Hospital
Nanning, China Recruiting -
Shanghai Ruijin Hospital
Shanghai, China Recruiting -
Ankang People's Hospital
Ankang, China Not yet recruiting -
Sinopharm Tongmei General Hospital
Datong, China Not yet recruiting
Show 5 more locations
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First Affiliated Hospital of Gannan Medical University
Ganzhou, China Not yet recruiting -
Zhejiang Provincial People's Hospital
Hangzhou, China Not yet recruiting -
Huaian First People's Hospital
Huaian, China Not yet recruiting -
Shaanxi Provincial People's Hospital
Xi'an, China Not yet recruiting -
Zhanjiang Central People's Hospital
Zhanjiang, China Not yet recruiting
Study contacts
- Study coordinator: Dayu Chen, Pharmacist in Charge, PharmD
- Email: cdy_pharmacy@njglyy.com
- Phone: +86-025-83106666-60924
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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.