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 volunteersQualifiers
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
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
28-day mortality
28-day mortality
Sequential Organ Failure Assessment (SOFA) score at 48 hours
SOFA score at 48 hours, higher SOFA score mean a worse outcome
Adverse events related to antibiotic within 28 days
Adverse events related to antibiotic within 28 days, defined by Naranjo scale.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Ruijin Hospital
Collaborator
Zhejiang Hospital
Collaborator