International Pediatric Fungal Network Database Agreement

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Investigator: Christopher C. Dvorak, MD
Sponsor: Duke University

Location(s): United States

Description

This study is a multicenter, national and international, prospective observational comparative effectiveness study which also employs a case-control study design based on prospectively identified cases and controls, as well as a general epidemiology database.

The primary aim of this study is to compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis. In order to accomplish the first aim, this study will utilize a controlled comparative effectiveness study design. The primary effectiveness endpoint for study aim 1 is the comparison of global response at 14 days of antifungal therapy between antifungal therapeutic classes. The secondary effectiveness endpoints for study aim 1 are comparative effectiveness of the 1) global response to antifungal therapy after 30 days and 2) all-cause mortality at 30 days.

The secondary aim is to validate a clinical prediction model for candidemia in pediatric intensive care unit. A subaim of this objective is to determine the incidence of invasive candidiasis in specific high risk pediatric subpopulations. For the second aim, concurrent with the comparative effectiveness study, a prospective case-control study will be performed to validate a previously derived clinical prediction model developed to identify critically ill children with candidemia. The endpoint for study objective 2 is the confirmation of the value of a prediction model for developing candidemia in PICU patients.

The tertiary objective is to characterize the frequency of all invasive fungal infections in pediatric patients. For the third aim, the investigators will use descriptive statistics to establish the frequency of hospital admissions involving an invasive fungal infection per total hospital admissions and total hospital days during the study period. The endpoint for aim 3 is to describe the incidence of pediatric invasive fungal infections relative to all pediatric admissions.