PEACE: Pediatric Antifungal Comparative Effectiveness
- Conditions
- Pediatric Invasive Candidiasis
- Interventions
- Drug: Observational antifungal therapy
- Registration Number
- NCT01869829
- Lead Sponsor
- Duke University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
- 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).
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatric Invasive Candidiasis Observational antifungal therapy Pediatric patients (age \> 120 days and \< 18 years) with documented proven or probable invasive candidiasis
- Primary Outcome Measures
Name Time Method Global response to antifungal therapy 14 days
- Secondary Outcome Measures
Name Time Method Global response of antifungal therapy 30 days All-cause mortality 30 days
Trial Locations
- Locations (35)
Ann and Robert Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's Mercy
🇺🇸Kansas City, Missouri, United States
Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States
Instuto Giannina Gaslini
🇮🇹Genoa, Italy
OHSU Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Children's Hospital and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Hospital d'Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Cleveland Clinic Children's
🇺🇸Cleveland, Ohio, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Seattle Children's
🇺🇸Seattle, Washington, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
Centro de Estudios en Infectologia Pediatricia
🇨🇴Cali, Colombia
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
The Hospital for Sick Children
🇨🇦Toronto, Canada
Centro Medico Imbanaco
🇨🇴Cali, Colombia
King Faisal Specialist Hospital & Research Center
🇸🇦Riyadh, Saudi Arabia
3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital
🇬🇷Thessaloniki, Greece
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
UCSF Benioff Children's Hospital
🇺🇸San Francisco, California, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
New York Presbyterian Phyllis and David Komansky Center for Children's Health
🇺🇸New York, New York, United States
Cohen Children's Medical Center of New York
🇺🇸New Hyde Park, New York, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Postgraduate Institute of Medical Education and Research
🇮🇳Chandigarh, India
Duke University
🇺🇸Durham, North Carolina, United States