Multicenter Validation of a Risk Prediction Model for MDRGNB Infection

ConditionInfection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult ICU patients

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Observation group

Trial outcomes

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.

Time frame
48 hours after ICU admission

Secondary outcomes

1

28-day mortality

28-day mortality

Time frame
28 day after ICU admission
2

Sequential Organ Failure Assessment (SOFA) score at 48 hours

SOFA score at 48 hours, higher SOFA score mean a worse outcome

Time frame
48 hours after ICU admission
3

Adverse events related to antibiotic within 28 days

Adverse events related to antibiotic within 28 days, defined by Naranjo scale.

Time frame
28 day after admission

Other outcomes

Sponsors and contacts

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