A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

Stopped early · Phase 3

Conditions studied: Invasive Aspergillosis

In brief

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.

Key facts

Study ID

NCT00836875

Run by

Pfizer

People needed

31

Starts

2009-05-01

Expected to finish

2013-05-01

Last updated by the study team

2017-06-16

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital & Research Center Oakland (CHRCO) — Oakland, California, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Children's Pavilion, Virginia Commonwealth University Health System — Richmond, Virginia, United States
• Virginia Commonwealth University Health System, Hospital Pharmacy — Richmond, Virginia, United States
• Pediatric Hematology and Oncology, Virginia Commonwealth University Health System — Richmond, Virginia, United States
• Virginia Commonwealth University/MCV Clinical Pathology — Richmond, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Alberta Children's Hospital, Pediatric Oncology Office — Calgary, Alberta, Canada
• Alberta Children's Hospital — Calgary, Alberta, Canada
• Fakultni nemocnice Brno — Brno, Czechia
• Fakultni nemocnice Brno — Brno, Czechia
• UMC St. Radboud — Nijmegen, Netherlands
• Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej — Wroclaw, Poland
• National University Hospital — Singapore, Singapore
• KK Women's and Children's Hospital — Singapore, Singapore
• Hospital General Universitari Vall D'Hebron — Barcelona, Spain
• Hospital Universitari Vall d'Hebron. Servicio de Farmacia — Barcelona, Spain
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• HOSPITAL UNIVERSITARIO 12 DE OCTUBRE Servicio de Farmacia — Madrid, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University — Bangkok Noi, Bangkok, Thailand
• Department of Pediatrics, Faculty of Medicine, Chulalongkorn University — Patumwan, Bangkok, Thailand
• Department of Pediatrics, Phramongkutklao hospital — Rajathevee, Bangkok, Thailand

Full record on ClinicalTrials.gov

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