Clinical trial NCT00836875: A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
Official title: A Prospective, Open-label, Non-randomized, Multi-center Study To Investigate The Safety And Tolerability Of Voriconazole As Primary Therapy For Treatment Of Invasive Aspergillosis And Molds Such As Scedosporium Or Fusarium Species In Pediatric Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Invasive Aspergillosis
Keywords: Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 31
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.


Eligibility criteria: Inclusion Criteria:

* Immunocompromised with clinically compatible illness.
* Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a modified version of the revised EORTC/MSG consensus definitions).
* Diagnosis of infection due to Scedosporium or Fusarium species.
* Male and female from 2 to 17 years of age.
* Females with childbearing potential must have negative pregnancy test and be using appropriate contraception.

Exclusion Criteria:

* Allergy or hypersensitivity to the azole drugs.
* Female subjects who are pregnant or lactating.
* Patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection.
* Received within 24 hours prior to enrollment drugs that may cause QT interval prolongation.
* Significant liver, kidney or heart dysfunction.
* Not expected to survive for at least 5 days.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment
Secondary outcomes:
measure: Percentage of Participants With a Global Response of Success
timeFrame: Weeks 6 and End of Treatment (EOT; up to Week 12)
measure: All-Cause Mortality - Number of Participant Deaths
timeFrame: Week 6 and EOT (up to Week 12)
measure: Attributable Mortality - Number of Participant Deaths
timeFrame: Weeks 6 and EOT (up to Week 12)
measure: Time to Death
timeFrame: Baseline up to 1 month post treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Oakland
country: United States
facility: Children's Hospital & Research Center Oakland (CHRCO)
state: California
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Richmond
country: United States
facility: Children's Pavilion, Virginia Commonwealth University Health System
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System, Hospital Pharmacy
state: Virginia
city: Richmond
country: United States
facility: Pediatric Hematology and Oncology, Virginia Commonwealth University Health System
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/MCV Clinical Pathology
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Calgary
country: Canada
facility: Alberta Children's Hospital, Pediatric Oncology Office
state: Alberta
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Wroclaw
country: Poland
facility: Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron. Servicio de Farmacia
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: HOSPITAL UNIVERSITARIO 12 DE OCTUBRE Servicio de Farmacia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Bangkok noi
country: Thailand
facility: Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University
state: Bangkok
city: Patumwan
country: Thailand
facility: Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
state: Bangkok
city: Rajathevee
country: Thailand
facility: Department of Pediatrics, Phramongkutklao hospital
state: Bangkok
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Martin JM, Macias-Parra M, Mudry P, Conte U, Yan JL, Liu P, Capparella MR, Aram JA. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. Pediatr Infect Dis J. 2017 Jan;36(1):e1-e13. doi: 10.1097/INF.0000000000001339.