PEACE (PEdiatric Antifungal Comparative Effectiveness)
IPFN Study 005: Comparative Effectiveness of Treatments of Pediatric Candidemia (NCT01869829)
Enrollment Completed, Analysis Ongoing
PEACE was a multi-center (US and international sites), prospective observational comparative-effectiveness study. The primary aim of the study was to compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and invasive candidemia. The study collected data on 750 events of proven/probably invasive candidiasis in children and adolescents.
The IPFN has multiple ongoing research projects dedicated to improving the diagnosis, treatment, and outcomes of pediatric patients with invasive fungal infections.
PEACE Study
BIOPIC (BIOmarkers for Pediatric Invasive Candidiasis)
IPFN Study 006: Evaluation of Fungal Biomarkers for Diagnosis of Pediatric Candidemia (NCT02220790)
Currently Enrolling
This study will determine if fungal biomarkers can improve the time to diagnosis of invasive candidiasis in high risk pediatric patients as compared to traditional blood cultures. Additionally, these same fungal biomarkers will be evaluated to measure response to antifungal treatment in those high risk patients that develop invasive candidiasis.
We will prospectively enroll 500 patients throughout all International Pediatric Fungal Network (IPFN) sites over 4 years. In order to increase the utility of these biomarkers, we will only enroll pediatric patients who are at “high-risk” for developing candidiasis (defined in inclusion criteria below, and based on previous epidemiologic studies). When an eligible patient has a blood culture drawn for clinical care, he or she will be enrolled and have research blood for biomarker testing drawn as soon as possible. The day that the clinical blood culture is drawn is "Day 0".
Most patients will not go on to develop invasive candidiasis, as defined by the international Mycoses Study Group / European Organization for the Treatment of Cancer (MSG/EORTC) definitions, and will not have any more blood drawn in this study. For those patients that do develop invasive candidiasis, we will also potentially draw study blood for the same biomarker tests on days +5, +7, and +14. This equates to 5, 7, and 14 days after “Day 0”.
Blood for biomarkers will be drawn from patients using the kits and tubes provided by the IPFN.
Inclusion Criteria for initial study enrollment
Inclusion criteria for subsequent research blood samples:
Exclusion Criteria
BIOPIC Study
International Pediatric Fungal Network, Box 3499, Duke University Medical Center, Durham, NC 27710. USA. Tel: 919-668-4847 Email: PFNContracts@duke.edu
Information about additional clinical trials for pediatric fungal infections can be found on ClinicalTrials.gov.