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PEACE: Pediatric Antifungal Comparative Effectiveness (PEACE)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Duke University
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01869829
First received: May 31, 2013
Last updated: June 21, 2017
Last verified: June 2017
  Purpose
The overarching objective is to 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 and for the subset of patients with invasive candidemia; 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: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Global response to antifungal therapy [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Global response of antifungal therapy [ Time Frame: 30 days ]
  • All-cause mortality [ Time Frame: 30 days ]

Other Outcome Measures:
  • Incidence of pediatric invasive fungal infections [ Time Frame: 4 years ]

Estimated Enrollment: 750
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   120 Days to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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. Documented proven or probable 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

  Show 35 Study Locations
Sponsors and Collaborators
Duke University
Children's Hospital of Philadelphia
National Institute of Allergy and Infectious Diseases (NIAID)
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:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01869829     History of Changes
Other Study ID Numbers: Pro00045657
1R01AI103315-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: May 31, 2013
Last Updated: June 21, 2017

Keywords provided by Duke University:
Candida
Pediatric
Antifungal

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Mycoses
Fluconazole
Voriconazole
Micafungin
Caspofungin
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Miconazole
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 23, 2017