Multicenter Validation of a Risk Prediction Model for MDRGNB Infection (PRIOR)

May 22, 2026 updated by: Chen Dayu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dayu Chen, Pharmacist in Charge, PharmD
  • Phone Number: +86-025-83106666-60924
  • Email: cdy_pharmacy@njglyy.com

Study Contact Backup

Study Locations

  • China
      • Ankang, China
        • Not yet recruiting
        • Ankang People's Hospital
        • Contact:
        • Principal Investigator:
          • Zhiying Gao
      • Datong, China
        • Not yet recruiting
        • Sinopharm Tongmei General Hospital
        • Contact:
          • Xiaomin Feng, Associate Professor
          • Phone Number: +86-0352-7028190
          • Email: Fxm10010@163.com
        • Principal Investigator:
          • Xiaomin Feng
      • Ganzhou, China
        • Not yet recruiting
        • First Affiliated Hospital of Gannan Medical University
        • Contact:
          • Peipei Liu, Pharmacist in Charge, PharmD
          • Phone Number: +86-0797-8266000
          • Email: liupei0322@163.com
        • Principal Investigator:
          • Peipei Liu
      • Hangzhou, China
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Xiaoyuan Chen
      • Hangzhou, China
        • Recruiting
        • Zhejiang Hospital
        • Contact:
          • Zhouye Song, Pharmacist in Charge
          • Phone Number: +86-0571-87987373
          • Email: szy1066@126.com
        • Principal Investigator:
          • Zhouye Song
      • Huaian, China
        • Not yet recruiting
        • Huaian First People's Hospital
        • Contact:
        • Principal Investigator:
          • Yu Du
      • Nanning, China
        • Recruiting
        • Guangxi Provincial Tumor Hospital
        • Contact:
          • Linyu Wang, Pharmacist in Charge
          • Phone Number: +86-0771-5331955
          • Email: 1044548733@qq.com
        • Principal Investigator:
          • Linyu Wang
      • Shanghai, China
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:
        • Principal Investigator:
          • Juan He
      • Xi'an, China
        • Not yet recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
          • Lu Cao, Associate Professor
          • Phone Number: +86-029-85251331
          • Email: caolu_cpu@163.com
        • Principal Investigator:
          • Lu Cao
      • Zhanjiang, China
        • Not yet recruiting
        • Zhanjiang Central People's Hospital
        • Contact:
          • Xi Cao, Pharmacist in Charge
          • Phone Number: +86-0759-3157999
          • Email: nkyy_cx@126.com
        • Principal Investigator:
          • Xi Cao
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
        • Sub-Investigator:
          • Yao Du, MPharm
        • Principal Investigator:
          • Dayu Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult ICU patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observation group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDRGNB infection
Time Frame: 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.
48 hours after ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 day after ICU admission
28-day mortality
28 day after ICU admission
Adverse events related to antibiotic within 28 days
Time Frame: 28 day after admission
Adverse events related to antibiotic within 28 days, defined by Naranjo scale.
28 day after admission
Sequential Organ Failure Assessment (SOFA) score at 48 hours
Time Frame: 48 hours after ICU admission
SOFA score at 48 hours, higher SOFA score mean a worse outcome
48 hours after ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborators

Ruijin Hospital
Zhejiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 16, 2026

First Submitted That Met QC Criteria

May 16, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0453-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified original data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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