Back to resultsTreatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Itraconazole
Sponsored by
About this trial
This is an interventional prevention trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Aspergillus Fumigatus, randomized controlled clinical trials
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
Sites / Locations
- Shawn Aaron, The Ottawa Hospital-General Campus
- Felix Ratjen, The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Itraconazole
Placebo
Arm Description
Itraconazole 5mg/kg/day for 24 weeks
Placebo/day for 24 weeks
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00528190
First Posted
September 10, 2007
Last Updated
April 3, 2017
Sponsor
Ottawa Hospital Research Institute
Collaborators
The Hospital for Sick Children, Canadian Cystic Fibrosis Foundation, The Physicians' Services Incorporated Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00528190
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
The Hospital for Sick Children, Canadian Cystic Fibrosis Foundation, The Physicians' Services Incorporated Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Aspergillus Fumigatus, randomized controlled clinical trials
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Itraconazole
Arm Type
Experimental
Arm Description
Itraconazole 5mg/kg/day for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo/day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Other Intervention Name(s)
non applicable
Intervention Description
Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn Aaron, MD
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shawn Aaron, The Ottawa Hospital-General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Felix Ratjen, The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22563440
Citation
Aaron SD, Vandemheen KL, Freitag A, Pedder L, Cameron W, Lavoie A, Paterson N, Wilcox P, Rabin H, Tullis E, Morrison N, Ratjen F. Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study. PLoS One. 2012;7(4):e36077. doi: 10.1371/journal.pone.0036077. Epub 2012 Apr 30.
Results Reference
derived
Learn more about this trial
Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis
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