PEACE: Pediatric Antifungal Comparative Effectiveness (PEACE)
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|ClinicalTrials.gov Identifier: NCT01869829|
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment|
|Pediatric Invasive Candidiasis||Drug: Observational antifungal therapy|
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 [Patient Registry]|
|Actual Enrollment :||750 participants|
|Target Follow-Up Duration:||7 Weeks|
|Official Title:||International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
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.
- Global response to antifungal therapy [ Time Frame: 14 days ]
- Global response of antifungal therapy [ Time Frame: 30 days ]
- All-cause mortality [ Time Frame: 30 days ]
- Incidence of pediatric invasive fungal infections [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869829
Show 35 Study Locations
|Principal Investigator:||William J Steinbach, MD||Duke University|
|Principal Investigator:||Theoklis E Zaoutis, MD MSCE||Children's Hospital of Philadelphia|