International Pediatric Fungal Network (PFN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01869829
First received: May 31, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Pediatric Invasive Candidiasis
Drug: Observational antifungal therapy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Global response to antifungal therapy at day 14 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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 30 days and 2) all-cause mortality at 30 days.

  • Global response of antifungal therapy at day 35 [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
    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.

  • All-cause mortality [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Development of candidemia while in PICU [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The secondary aim is to validate a clinical prediction model for candidemia in pediatric intensive care unit. A subaim of this objective is to determine the incidence of invasive candidiasis in specific high risk pediatric subpopulations. For the second aim, concurrent with the comparative effectiveness study, a prospective case-control study will be performed to validate a previously derived clinical prediction model developed to identify critically ill children with candidemia. The endpoint for study objective 2 is the confirmation of the value of a prediction model for developing candidemia in PICU patients.


Other Outcome Measures:
  • Describe incidence of pediatric invasive fungal infections [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The tertiary objective is to characterize the frequency of all invasive fungal infections in pediatric patients. For the third aim, the investigators will use descriptive statistics to establish the frequency of hospital admissions involving an invasive fungal infection per total hospital admissions and total hospital days during the study period. The endpoint for aim 3 is to describe the incidence of pediatric invasive fungal infections relative to all pediatric admissions.


Estimated Enrollment: 1000
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)
Groups/Cohorts Assigned Interventions
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.

Other Names:
  • fluconazole
  • voriconazole
  • amphotericin B
  • caspofungin
  • micafungin
Pediatric patients with other invasive fungal infections
Patients with proven or probable invasive fungal infection that are not Candida, to be collected for general epidemiologic information
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.

Other Names:
  • fluconazole
  • voriconazole
  • amphotericin B
  • caspofungin
  • micafungin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   120 Days to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pediatric patients with invasive candidiasis

Criteria

Inclusion Criteria:

  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).

Exclusion Criteria:

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869829

Contacts
Contact: William J Steinbach, MD 919-684-3734 bill.steinbach@duke.edu

Locations
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: William J Steinbach, MD    919-684-3734    bill.steinbach@duke.edu   
Contact: Ava A Brozovich, MPH    919-668-4847    ava.brozovich@duke.edu   
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Theoklis E Zaoutis, MD    267-426-5570    zaoutis@email.chop.edu   
Sponsors and Collaborators
Duke University
Children's Hospital of Philadelphia
Investigators
Principal Investigator: William J Steinbach, MD Duke University
Principal Investigator: Theoklis E Zaoutis, MD MSCE Children's Hospital of Philadelphia
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01869829     History of Changes
Other Study ID Numbers: Pro00045657, 1R01AI103315-01A1
Study First Received: May 31, 2013
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Candida
Pediatric
Antifungal

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Mycoses
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Clotrimazole
Miconazole
Fluconazole
Voriconazole
Caspofungin
Micafungin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014