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

Official Title: “Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial”

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.

The aim of this study is to determine whether antibiotic treatment directed against Aspergillus Fumigatus will be effective at preventing respiratory exacerbations and improving pulmonary function in patients with cystic fibrosis(CF) who are chronically colonized/infected with aspergillus. This aim will be accompanied by means of a randomized, double-blind, placebo-controlled clinical trial incorporating two parallel treatment arms.

Intervention(s) in this Clinical Trial

• Drug: Itraconazole
  • Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Itraconazole
  • Itraconazole 5mg/kg/day
• Placebo Comparator: Placebo

Primary Measures

• The Primary outcome measure will be the proportion of patients who experience a respiratory exacerbation requiring intravenous antibiotics in the two treatment groups over the 24 week trial treatment period.
  • Time Frame: 24 weeks
    Safety Issue?: Yes

Secondary Measures

• respiratory exacerbation requiring intravenous or oral antibiotics over the 24 week trial treatment period. 2) Absolute and relative changes in the force
  • Time Frame: 48 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Ottawa Hospital Research Institute Other

Overall Clinical Trial Officials and Contacts

Shawn Aaron, MD Principal Investigator OHRI  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00528190

Study ID Number: 2006768

ClinicalTrials.gov Identifier: NCT00528190

Health Authority: Canada: Health Canada