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Eligibility
for people ages up to 18 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

The overarching objective is to ultimately develop new evidence-based treatment guidelines for invasive fungal infections 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; 2) Characterize the incidence of pediatric invasive candidiasis.

Official Title

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

Details

This study is a multicenter, national and international, prospective observational comparative effectiveness study which also employs a case-control study design based on prospectively identified cases and controls, as well as a general epidemiology database.

The primary aim of this study is to compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis. In order to accomplish the first aim, this study will utilize a controlled comparative effectiveness study design. 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 35 days and 2) all-cause mortality at 35 days.

The secondary aim is to characterize the frequency of pediatric candidiasis. 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. The endpoint for aim 2 is to describe the incidence of pediatric candidiasis relative to all pediatric admissions.

Keywords

Pediatric Invasive Candidiasis Candida Pediatric Antifungal Micafungin Caspofungin Amphotericin B Liposomal amphotericin B Antifungal Agents Miconazole Fluconazole Voriconazole

Eligibility

You can join if…

Open to people ages up to 18 years

  1. Males or females age> 120 days and <18 years
  2. Incident case of invasive candidiasis
  3. Parental/guardian permission (informed consent, if required) and if appropriate,child assent (if required).

You CAN'T join if...

1) 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)

Locations

  • Lucile Packard Children's Hospital at Stanford accepting new patients
    Palo Alto, California, United States
  • Children's Hospital of Orange County accepting new patients
    Orange, California, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
Links
International Pediatric Fungal Network
ID
NCT01869829
Study Type
Observational [Patient Registry]
Last Updated
July 1, 2016
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