The overarching objective is to ultimately develop new evidence-based treatment guidelines for invasive fungal infections in children. To accomplish that, this protocol will focus on two specific aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis; 2) Characterize the incidence of pediatric invasive candidiasis.
International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis
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 35 days and 2) all-cause mortality at 35 days.
The secondary aim is to characterize the frequency of pediatric candidiasis. For this aim, the investigators will use descriptive statistics to establish the frequency of hospital admissions involving an invasive candidiasis per total hospital admissions and total hospital days during the study period. The endpoint for aim 2 is to describe the incidence of pediatric candidiasis relative to all pediatric admissions.