PEACE: Pediatric Antifungal Comparative Effectiveness

Duke University

Status: Completed

Conditions: Pediatric Invasive Candidiasis

Treatments: Drug: Observational antifungal therapy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01869829

Pro00045657

1R01AI103315-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 750 patients

Sex: All

Ages: 120 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females age > 120 days and <18 years
2. Documented proven or probable case of invasive candidiasis
3. 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)

Trial design

750 participants in 1 patient group

Pediatric Invasive Candidiasis

Description:

Pediatric patients (age \> 120 days and \< 18 years) with documented proven or probable invasive candidiasis

Treatment:

Drug: Observational antifungal therapy