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PEACE: Pediatric Antifungal Comparative Effectiveness (PEACE)

This study is currently recruiting participants.
Verified July 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01869829
First Posted: June 5, 2013
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Children's Hospital of Philadelphia
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Duke University
  Purpose
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 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

All agents are given as standard of care.


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

Information from the National Library of Medicine

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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
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


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 ( U.S. NIH Grant/Contract )
First Submitted: May 31, 2013
First Posted: June 5, 2013
Last Update Posted: July 13, 2017
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