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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Invasive Aspergillosis

Treatments: Drug: Voriconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00836875

A1501080

2008-005275-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

31 participants in 1 patient group

1

Experimental group

Description:

Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).

Treatment:

Drug: Voriconazole