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

This study has been completed.
Sponsor:
Collaborators:
The Hospital for Sick Children
Canadian Cystic Fibrosis Foundation
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00528190
First received: September 10, 2007
Last updated: September 23, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
 Drug: Itraconazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2007
Study Completion Date: May 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Itraconazole
Itraconazole 5mg/kg/day
 Drug: Itraconazole
Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
Other Name: non applicable
Placebo Comparator: Placebo Drug: Itraconazole
Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
Other Name: non applicable

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528190

Locations
Canada, Ontario
Shawn Aaron, The Ottawa Hospital-General Campus
Ottawa, Ontario, Canada, K1H 8L6
Felix Ratjen, The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Hospital for Sick Children
Canadian Cystic Fibrosis Foundation
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Shawn Aaron, MD OHRI
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00528190     History of Changes
Other Study ID Numbers: 2006768
Study First Received: September 10, 2007
Last Updated: September 23, 2011
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Cystic Fibrosis
Aspergillus Fumigatus
randomized controlled clinical trials

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
 Itraconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013