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Multicenter Validation of a Risk Prediction Model for MDRGNB Infection

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07603128
Acronym
PRIOR
Enrollment
1000
Registered
2026-05-22
Start date
2026-05-22
Completion date
2028-12-31
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Prediction model, MDRGNB, ICU, Infection

Brief summary

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

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.

Interventions

None listed

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER
Ruijin Hospital
CollaboratorOTHER
Zhejiang Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MDRGNB infection48 hours after ICU admissionThe 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.

Secondary

MeasureTime frameDescription
28-day mortality28 day after ICU admission28-day mortality
Sequential Organ Failure Assessment (SOFA) score at 48 hours48 hours after ICU admissionSOFA score at 48 hours, higher SOFA score mean a worse outcome
Adverse events related to antibiotic within 28 days28 day after admissionAdverse events related to antibiotic within 28 days, defined by Naranjo scale.

Countries

China

Contacts

CONTACTDayu Chen, Pharmacist in Charge, PharmD
cdy_pharmacy@njglyy.com+86-025-83106666-60924
CONTACTJuan He, Professor, PharmD
hejuanwin@126.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026