DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 14

Global 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017