Status:
TERMINATED
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
Lead Sponsor:
Pfizer
Conditions:
Invasive Aspergillosis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
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
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00836875
Start Date
May 1 2009
End Date
May 1 2013
Last Update
June 16 2017
Active Locations (25)
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1
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Children's Hospital & Research Center Oakland (CHRCO)
Oakland, California, United States, 94609
3
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030