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NCT Number: NCT07603128

Multicenter Validation of a Risk Prediction Model for MDRGNB Infection

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 28-day mortality

    Time frame: 28 day after ICU admission

    28-day mortality

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dayu Chen, Pharmacist in Charge, PharmD

CONTACT

[email protected]

+86-025-83106666-60924

Juan He, Professor, PharmD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Collaborators

  • Ruijin Hospital
  • Zhejiang Hospital

Registry information

Official study title

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

Acronym: PRIOR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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