Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial will attempt to determine whether we can improve clinical outcomes for patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Cystic Fibrosis Foundation; The Hospital for Sick Children; The Physicians' Services Incorporated Foundation
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria

• Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations

• Patient must be known to be chronically colonized with Aspergillus fumigatus.

• Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization.

• 6 years of age and older

• Patients must weigh at least 20 kg

• Post-menarche females must be using an effective form of contraception.

Exclusion Criteria

• Inability to give informed consent.

• Respiratory culture positive for B.cepacia complex

• Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization

• Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization

• Neutropenia, absolute neutrophil count< or = 1000 within a 3-day period prior to randomization

• History of biliary cirrhosis documented by liver biopsy or imaging.

• History of portal hypertension.

• Investigational drug use within 30 days of randomization date.

• History of alcohol, illicit drug or medication abuse within 1 year of randomization.

• Women who are pregnant, breastfeeding or trying to conceive