Clinical trial Recruiting at 4 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Academic / other
Locations11 sites (Nanjing, Jiangsu and 10 other locations)
StatusRecruiting
StartedMay 22, 2026
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedMay 27, 2026
Trial IDNCT07603128 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.