Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
750 participants
OBSERVATIONAL
2015-01-31
2018-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pediatric Invasive Candidiasis
Pediatric patients (age \> 120 days and \< 18 years) with documented proven or probable invasive candidiasis
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
120 Days
18 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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William J Steinbach, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Theoklis E Zaoutis, MD MSCE
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
Rady Children's Hospital
San Diego, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
All Children's Hospital
St. Petersburg, Florida, United States
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy
Kansas City, Missouri, United States
Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
New York Presbyterian Phyllis and David Komansky Center for Children's Health
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Children's
Cleveland, Ohio, United States
OHSU Doernbecher Children's Hospital
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Dell Children's Medical Center
Austin, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
The Hospital for Sick Children
Toronto, , Canada
Centro de Estudios en Infectologia Pediatricia
Cali, , Colombia
Centro Medico Imbanaco
Cali, , Colombia
3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital
Thessaloniki, , Greece
Postgraduate Institute of Medical Education and Research
Chandigarh, , India
Instuto Giannina Gaslini
Genoa, , Italy
King Faisal Specialist Hospital & Research Center
Riyadh, , Saudi Arabia
Hospital d'Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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References
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Fisher BT, Zaoutis TE, Xiao R, Wattier RL, Castagnola E, Pana ZD, Fullenkamp A, Boge CLK, Ross RK, Yildirim I, Palazzi DL, Danziger-Isakov L, Vora SB, Arrieta A, Yin DE, Aviles-Robles M, Sharma T, Tribble AC, Maron G, Berman D, Green M, Sung L, Romero J, Hauger SB, Roilides E, Belani K, Nolt D, Soler-Palacin P, Lopez-Medina E, Muller WJ, Halasa N, Dulek D, Hussain IZB, Pong A, Hoffman J, Rajan S, Gonzalez BE, Hanisch B, Aftandilian C, Carlesse F, Abzug MJ, Huppler AR, Salvatore CM, Ardura MI, Chakrabarti A, Santolaya ME, Localio AR, Steinbach WJ. Comparative Effectiveness of Echinocandins vs Triazoles or Amphotericin B Formulations as Initial Directed Therapy for Invasive Candidiasis in Children and Adolescents. J Pediatric Infect Dis Soc. 2021 Aug 10:piab024. doi: 10.1093/jpids/piab024. Online ahead of print.
Related Links
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International Pediatric Fungal Network
Other Identifiers
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Pro00045657
Identifier Type: -
Identifier Source: org_study_id
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