PEACE: Pediatric Antifungal Comparative Effectiveness

Study Overview
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Brief Summary
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The overarching objective is to develop new evidence-based treatment guidelines for invasive fungal diseases 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 and for the subset of patients with invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive candidiasis per hospital admissions.

Detailed Description
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This study is a multicenter, national and international, prospective observational comparative effectiveness study. The primary aim of this study is to compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for invasive candidemia. 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 characterize the frequency of pediatric candidiasis by describing the incidence of pediatric candidiasis relative to all pediatric admissions. 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.

Official Title
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International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis

Conditions
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Pediatric Invasive Candidiasis

Intervention / Treatment
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* Drug: Observational antifungal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age > 120 days and <18 years Documented proven or probable case of invasive candidiasis Parental/guardian permission (informed consent, if required) and if appropriate, child assent (if required). Exclusion Criteria: 1) Any history of prior Candida infection within the previous 35 days (These patients will not be eligible for analysis in aim 1 but will be eligible for inclusion of aim 2)

Ages Eligible for Study
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Minimum Age: 120 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Invasive Candidiasis<br>Pediatric patients (age > 120 days and < 18 years) with documented proven or probable invasive candidiasis | Drug: Observational antifungal therapy<br>* Observational study of primary antifungal therapy utilized and outcomes, including: fluconazole, voriconazole, amphotericin B, caspofungin, and micafungin All agents are given as standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global response to antifungal therapy |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global response of antifungal therapy |  | 30 days | 
| All-cause mortality |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Candida, Pediatric, Antifungal