Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis (NCT00528190) | Clinical Trial Compass
CompletedPhase 4
Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis
Canada35 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range6 Years
SexALL
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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
What they're measuring
1
The Primary Outcome Measure Will be the Number of Patients Who Experience a Respiratory Exacerbation Requiring Intravenous Antibiotics in the Two Treatment Groups Over the 24 Week Trial Treatment Period.