PEACE: Pediatric Antifungal Comparative Effectiveness

Completed

• Conditions: Pediatric Invasive Candidiasis
• Interventions: Drug: Observational antifungal therapy

• Registration Number: NCT01869829
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-05-31
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-05
• Study Start: 2015-01
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Invasive Candidiasis	Observational antifungal therapy	Pediatric patients (age \> 120 days and \< 18 years) with documented proven or probable invasive candidiasis

Primary Outcome Measures

Name	Time	Method
Global response to antifungal therapy	14 days

Secondary Outcome Measures

Name	Time	Method
Global response of antifungal therapy	30 days
All-cause mortality	30 days

Trial Locations

Locations (35)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

Lucile Packard Children's Hospital at Stanford; 🇺🇸 Palo Alto, California, United States

Rady Children's Hospital; 🇺🇸 San Diego, California, United States

UCSF Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States

Ann and Robert Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

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