PEACE: Pediatric Antifungal Comparative Effectiveness (PEACE)
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||7 Weeks|
|Official Title:||International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis|
- 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 ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
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
Antifungal agents agreed upon (and dosing) at each site.
All agents are given as standard of care.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01869829
|Contact: William J Steinbach, MDemail@example.com|
Show 35 Study Locations
|Principal Investigator:||William J Steinbach, MD||Duke University|
|Principal Investigator:||Theoklis E Zaoutis, MD MSCE||Children's Hospital of Philadelphia|