Phase 4
N=35
Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00528190 ↗Enrolled (actual)
35
Serious AEs
2.9%
Results posted
Mar 2017
Primary outcome: Primary: 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. — 4; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Itraconazole (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
4; 5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00528190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.