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

Phase 4

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Itraconazole

• Registration Number: NCT00528190
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Study Timeline

• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Study Start: 2007-10
• Primary Completion: 2010-08
• Study Completion: 2011-05
• Status Verified: 2017-02
• Results First Submitted: 2017-02-01
• Results First Submitted QC: 2017-02-01
• Results First Posted: 2017-03-23
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Itraconazole	Placebo/day for 24 weeks
Itraconazole	Itraconazole	Itraconazole 5mg/kg/day for 24 weeks

Primary Outcome Measures

Name	Time	Method
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.	24 weeks	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.

Trial Locations

Locations (2)

Shawn Aaron, The Ottawa Hospital-General Campus; 🇨🇦 Ottawa, Ontario, Canada

Felix Ratjen, The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada