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

Cystic Fibrosis Clinical Trial

Official title:

Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528190
• Other study ID #: 2006768
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2007
• Last updated: September 23, 2011
• Start date: October 2007
• Est. completion date: May 2011

Study information

• Verified date: September 2011
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Itraconazole
Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks

Locations

Country	Name	City	State
Canada	Shawn Aaron, The Ottawa Hospital-General Campus	Ottawa	Ontario
Canada	Felix Ratjen, The Hospital for Sick Children	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Cystic Fibrosis Foundation, The Hospital for Sick Children, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 weeks	Yes
Secondary	respiratory exacerbation requiring intravenous or oral antibiotics over the 24 week trial treatment period. 2) Absolute and relative changes in the force		48 weeks	Yes