PEACE: Pediatric Antifungal Comparative Effectiveness (PEACE)

January 14, 2022 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • The Hospital for Sick Children
  • Colombia
      • Cali, Colombia
        • Centro Médico Imbanaco
      • Cali, Colombia
        • Centro de Estudios en Infectologia Pediatricia
  • Greece
      • Thessaloniki, Greece
        • 3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital
  • India
      • Chandigarh, India
        • Postgraduate Institute of Medical Education and Research
  • Italy
      • Genoa, Italy
        • Instuto Giannina Gaslini
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Faisal Specialist Hospital & Research Center
  • Spain
      • Barcelona, Spain
        • Hospital d'Universitari Vall d'Hebron
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Arkansas Children's Hospital
    • California
      • Orange, California, United States
        • Children's Hospital of Orange County
      • Palo Alto, California, United States
        • Lucile Packard Children's Hospital at Stanford
      • San Diego, California, United States
        • Rady Children's Hospital
      • San Francisco, California, United States
        • UCSF Benioff Children's Hospital
    • Colorado
      • Aurora, Colorado, United States
        • Children's Hospital Colorado
    • District of Columbia
      • Washington, District of Columbia, United States
        • Children's National Medical Center
    • Florida
      • Saint Petersburg, Florida, United States
        • All Children's Hospital
    • Illinois
      • Chicago, Illinois, United States
        • Ann and Robert Lurie Children's Hospital of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States
        • Mott Children's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Children's Hospital and Clinics of Minnesota
    • Missouri
      • Kansas City, Missouri, United States
        • Children's Mercy
    • New York
      • New Hyde Park, New York, United States
        • Cohen Children's Medical Center of New York
      • New York, New York, United States
        • New York Presbyterian Phyllis and David Komansky Center for Children's Health
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States
        • Cincinnati Children's Medical Center
      • Cleveland, Ohio, United States
        • Cleveland Clinic Children's
    • Oregon
      • Portland, Oregon, United States
        • OHSU Doernbecher Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States
        • Children's Hospital of Pittsburgh
    • Tennessee
      • Memphis, Tennessee, United States
        • St. Jude Children's Research Hospital
      • Nashville, Tennessee, United States
        • Monroe Carell Jr. Children's Hospital at Vanderbilt
    • Texas
      • Austin, Texas, United States
        • Dell Children's Medical Center
      • Houston, Texas, United States
        • Texas Children's Hospital
    • Washington
      • Seattle, Washington, United States
        • Seattle Children's
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric patients with invasive candidiasis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric Invasive Candidiasis
Pediatric patients (age > 120 days and < 18 years) with documented proven or probable invasive candidiasis
Drug: Observational antifungal therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global response to antifungal therapy
Time Frame: 14 days
14 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of pediatric invasive fungal infections
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

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

Investigators

  • Principal Investigator: Theoklis E Zaoutis, MD MSCE, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

May 31, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (ESTIMATE)

June 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00045657
  • 1R01AI103315-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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