Clinical trial NCT01869829: PEACE: Pediatric Antifungal Comparative Effectiveness
Official title: International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Invasive Candidiasis
Keywords: Candida
Pediatric
Antifungal
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2013-06-05
Enrollment: 750
Sex: ALL
Minimum age (years): 120
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients with invasive candidiasis

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.

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 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)

Primary outcomes:
measure: Global response to antifungal therapy
timeFrame: 14 days
Secondary outcomes:
measure: Global response of antifungal therapy
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 30 days
Other outcomes:
measure: Incidence of pediatric invasive fungal infections
timeFrame: 4 years
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Saint Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Chicago
country: United States
facility: Ann and Robert Lurie Children's Hospital of Chicago
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Mott Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Children's Hospital and Clinics of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy
state: Missouri
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of New York
state: New York
city: New York
country: United States
facility: New York Presbyterian Phyllis and David Komansky Center for Children's Health
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Children's
state: Ohio
city: Portland
country: United States
facility: OHSU Doernbecher Children's Hospital
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: The Hospital for Sick Children
city: Cali
country: Colombia
facility: Centro de Estudios en Infectologia Pediatricia
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
city: Thessaloniki
country: Greece
facility: 3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
city: Genoa
country: Italy
facility: Instuto Giannina Gaslini
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Barcelona
country: Spain
facility: Hospital d'Universitari Vall d'Hebron
Study officials:
affiliation: Duke University
name: William J Steinbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Theoklis E Zaoutis, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.