Multicenter Validation of a Risk Prediction Model for MDRGNB Infection

NCT07603128 | Not Yet Recruiting DMC

• 1 other identifier: 2026-0453-02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Infection

Keywords

Prediction model; MDRGNB; ICU; Infection

Outcome Measures

Primary Outcomes (1)

• MDRGNB infection

  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 Outcomes (3)

• 28-day mortality

  28 day after ICU admission

• SOFA score at 48 hours

  48 hours after ICU admission

• Adverse events related to antibiotic within 28 days

  28 day after admission

Study Arms (1)

Observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult ICU patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• Ruijin Hospital: collaborator
• Zhejiang Hospital: collaborator

Study Sites (11)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Ankang People's Hospital

Ankang, China

Location

Sinopharm Tongmei General Hospital

Datong, China

Location

First Affiliated Hospital of Gannan Medical University

Ganzhou, China

Location

Zhejiang Hospital

Hangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Huaian First People's Hospital

Huaian, China

Location

Guangxi Provincial Tumor Hospital

Nanning, China

Location

Shanghai Ruijin Hospital

Shanghai, China

Location

Shaanxi Provincial People's Hospital

Xi'an, China

Location

Zhanjiang Central People's Hospital

Zhanjiang, China

Location

MeSH Terms

Conditions

Infections

Central Study Contacts

Dayu Chen, Pharmacist in Charge, PharmD

CONTACT

+86-025-83106666-60924; cdy_pharmacy@njglyy.com

Juan He, Professor, PharmD

CONTACT

hejuanwin@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist in Charge

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (11)