PEACE: Pediatric Antifungal Comparative Effectiveness

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT01869829

Collaborator

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

750

Enrollment

Locations

Duration (Months)

21.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Invasive Candidiasis	Drug: Observational antifungal therapy

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Global response to antifungal therapy [14 days]

Secondary Outcome Measures

Global response of antifungal therapy [30 days]
All-cause mortality [30 days]

Other Outcome Measures

Incidence of pediatric invasive fungal infections [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

120 Days to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Hospital	Little Rock	Arkansas	United States
2	Children's Hospital of Orange County	Orange	California	United States
3	Lucile Packard Children's Hospital at Stanford	Palo Alto	California	United States
4	Rady Children's Hospital	San Diego	California	United States
5	UCSF Benioff Children's Hospital	San Francisco	California	United States
6	Children's Hospital Colorado	Aurora	Colorado	United States
7	Children's National Medical Center	Washington	District of Columbia	United States
8	All Children's Hospital	Saint Petersburg	Florida	United States
9	Ann and Robert Lurie Children's Hospital of Chicago	Chicago	Illinois	United States
10	Boston Children's Hospital	Boston	Massachusetts	United States
11	Mott Children's Hospital	Ann Arbor	Michigan	United States
12	Children's Hospital and Clinics of Minnesota	Minneapolis	Minnesota	United States
13	Children's Mercy	Kansas City	Missouri	United States
14	Cohen Children's Medical Center of New York	New Hyde Park	New York	United States
15	New York Presbyterian Phyllis and David Komansky Center for Children's Health	New York	New York	United States
16	Duke University	Durham	North Carolina	United States	27710
17	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States
18	Cleveland Clinic Children's	Cleveland	Ohio	United States
19	OHSU Doernbecher Children's Hospital	Portland	Oregon	United States
20	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
21	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States
22	St. Jude Children's Research Hospital	Memphis	Tennessee	United States
23	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	United States
24	Dell Children's Medical Center	Austin	Texas	United States
25	Texas Children's Hospital	Houston	Texas	United States
26	Seattle Children's	Seattle	Washington	United States
27	Medical College of Wisconsin	Milwaukee	Wisconsin	United States
28	The Hospital for Sick Children	Toronto		Canada
29	Centro de Estudios en Infectologia Pediatricia	Cali		Colombia
30	Centro Medico Imbanaco	Cali		Colombia
31	3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital	Thessaloniki		Greece
32	Postgraduate Institute of Medical Education and Research	Chandigarh		India
33	Instuto Giannina Gaslini	Genoa		Italy
34	King Faisal Specialist Hospital & Research Center	Riyadh		Saudi Arabia
35	Hospital d'Universitari Vall d'Hebron	Barcelona		Spain

Sponsors and Collaborators

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

Investigators

Principal Investigator: William J Steinbach, MD, Duke University
Principal Investigator: Theoklis E Zaoutis, MD MSCE, Children's Hospital of Philadelphia