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NCT Number: NCT01869829

PEACE: Pediatric Antifungal Comparative Effectiveness

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.

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Key information

Age range

120 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children, Toronto, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Observational antifungal therapy

Drug

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.

Primary outcomes

  1. Global response to antifungal therapy

    Time frame: 14 days

Secondary outcomes

  1. Global response of antifungal therapy

    Time frame: 30 days

  2. All-cause mortality

    Time frame: 30 days

Other outcomes

  1. Incidence of pediatric invasive fungal infections

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Children's Hospital of Philadelphia
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Acronym: PEACE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2013
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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