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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

September 10, 2007
September 23, 2011
October 2007
August 2010   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00528190 on ClinicalTrials.gov Archive Site
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 ]
respiratory exacerbation requiring intravenous or oral antibiotics over the 24 week trial treatment period. 2) Absolute and relative changes in the force
Not Provided
Not Provided
 
Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cystic Fibrosis
Drug: Itraconazole
Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
Other Name: non applicable
  • Experimental: Itraconazole
    Itraconazole 5mg/kg/day
    Intervention: Drug: Itraconazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Itraconazole
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. Epub 2012 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2011
August 2010   (final data collection date for primary outcome measure)

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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00528190
2006768
Yes
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
  • The Hospital for Sick Children
  • Canadian Cystic Fibrosis Foundation
  • The Physicians' Services Incorporated Foundation
Principal Investigator: Shawn Aaron, MD OHRI
Ottawa Hospital Research Institute
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP