Multicenter Validation of a Risk Prediction Model for MDRGNB Infection

NCT07603128 · tracked via the Priya Life Science China tracker

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Phase

Observational

Started

2026-05-22

Last updated

2026-05-27

Condition(s) studied

Infection

Study summary

This prospective multicenter validation study aimed to evaluate the predictive performance of a previously developed model for MDRGNB infection in ICU patients.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

MDRGNB infection — 48 hours after ICU admission
The objective of this study was to observe whether enrolled patients developed early MDRGNB infection and to validate the model's performance. The occurrence of MDRGNB infection was adjudicated by integrating clinical manifestations with culture results from collected specimens.Baseline and model variables: Collected within 48 hours of ICU admission.Primary outcome: Determined based on the results of the first submitted specimen.

Trial sites (11)

Facility	City	Region	Status
Nanjing Drum Tower Hospital	Nanjing	Jiangsu	Recruiting
Ankang People's Hospital	Ankang	China	Not Yet Recruiting
Sinopharm Tongmei General Hospital	Datong	China	Not Yet Recruiting
First Affiliated Hospital of Gannan Medical University	Ganzhou	China	Not Yet Recruiting
Zhejiang Hospital	Hangzhou	China	Recruiting
Zhejiang Provincial People's Hospital	Hangzhou	China	Not Yet Recruiting
Huaian First People's Hospital	Huaian	China	Not Yet Recruiting
Guangxi Provincial Tumor Hospital	Nanning	China	Recruiting
Shanghai Ruijin Hospital	Shanghai	China	Recruiting
Shaanxi Provincial People's Hospital	Xi'an	China	Not Yet Recruiting
Zhanjiang Central People's Hospital	Zhanjiang	China	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07603128 on ClinicalTrials.gov ↗ ← All trials in China