NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)
NCT05189925
Chronic Disease, Chronic Granulomatous Disease
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT07603128
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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Request Info18 year and older
All sexes
Observational
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 28 day after ICU admission
28-day mortality
Time frame: 48 hours after ICU admission
SOFA score at 48 hours, higher SOFA score mean a worse outcome
Time frame: 28 day after admission
Adverse events related to antibiotic within 28 days, defined by Naranjo scale.
Contact information is provided by the study sponsor or research team.
Dayu Chen, Pharmacist in Charge, PharmD
CONTACT
Juan He, Professor, PharmD
CONTACT
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study
Acronym: PRIOR
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