PEACE: Pediatric Antifungal Comparative Effectiveness
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Invasive Candidiasis
Intervention: Observational antifungal therapy (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
William J Steinbach, MD, Principal Investigator, Affiliation: Duke University
Theoklis E Zaoutis, MD MSCE, Principal Investigator, Affiliation: Children's Hospital of Philadelphia
Overall contact:
William J Steinbach, MD, Phone: 919-684-3734, Email: bill.steinbach@duke.edu
Summary
The overarching objective is to ultimately develop new evidence-based treatment guidelines
for invasive fungal infections 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; 2) Characterize the
incidence of pediatric invasive candidiasis.
Clinical Details
Official title: International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: Global response to antifungal therapy at day 14Global response of antifungal therapy at day 35 All-cause mortality
Secondary outcome: Development of candidemia while in PICU
Detailed description:
This study is a multicenter, national and international, prospective observational
comparative effectiveness study which also employs a case-control study design based on
prospectively identified cases and controls, as well as a general epidemiology database.
The primary aim of this study is to compare the effectiveness of echinocandin versus
amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis. In order
to accomplish the first aim, this study will utilize a controlled comparative effectiveness
study design. 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 35 days and 2) all-cause mortality at 35 days.
The secondary aim is to characterize the frequency of pediatric candidiasis. 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. The endpoint for aim 2 is to describe the incidence
of pediatric candidiasis relative to all pediatric admissions.
Eligibility
Minimum age: 120 Days.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Males or females age > 120 days and <18 years
2. Incident 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)
Locations and Contacts
William J Steinbach, MD, Phone: 919-684-3734, Email: bill.steinbach@duke.edu
Duke University, Durham, North Carolina 27710, United States; Recruiting
William J Steinbach, MD, Phone: 919-684-3734, Email: bill.steinbach@duke.edu
Ava A Brozovich, MPH, Phone: 919-668-4847, Email: ava.brozovich@duke.edu
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Theoklis E Zaoutis, MD, Phone: 267-426-5570, Email: zaoutis@email.chop.edu
Additional Information
International Pediatric Fungal Network
Starting date: July 2013
Last updated: February 19, 2015
|
