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PEACE: Pediatric Antifungal Comparative Effectiveness (PEACE)

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ClinicalTrials.gov Identifier: NCT01869829
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
The overarching objective is to develop new evidence-based treatment guidelines for invasive fungal diseases 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 rate of inpatient pediatric invasive candidiasis per hospital admissions.

Condition or disease Intervention/treatment
Pediatric Invasive Candidiasis Drug: Observational antifungal therapy

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.


Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 750 participants
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
Study Start Date : January 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Groups and Cohorts
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Group/Cohort Intervention/treatment
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

All agents are given as standard of care.


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

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

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

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869829


  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
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Additional Information:
International Pediatric Fungal Network  This link exits the ClinicalTrials.gov site

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01869829     History of Changes
Other Study ID Numbers: Pro00045657
1R01AI103315-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: July 2017

Keywords provided by Duke University:
Candida
Pediatric
Antifungal

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Mycoses
Invasive Fungal Infections
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 CYP3A Inhibitors