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

• ClinicalTrials.gov Identifier: NCT00528190
• Recruitment Status: Completed
• First Posted: September 12, 2007
• Results First Posted: March 23, 2017
• Last Update Posted: May 10, 2017
• Sponsor: Ottawa Hospital Research Institute
• Collaborators: The Hospital for Sick Children; Canadian Cystic Fibrosis Foundation; The Physicians' Services Incorporated Foundation
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

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.

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis	Drug: Itraconazole	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial
• Study Start Date: October 2007
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Itraconazole; Itraconazole 5mg/kg/day for 24 weeks	Drug: Itraconazole; Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks; Other Name: non applicable
Placebo Comparator: Placebo; Placebo/day for 24 weeks	Drug: Itraconazole; Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks; Other Name: non applicable

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 6 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

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

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.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT00528190
• Other Study ID Numbers: 2006768
• First Posted: September 12, 2007
• Results First Posted: March 23, 2017
• Last Update Posted: May 10, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Ottawa Hospital Research Institute:

Cystic Fibrosis; Aspergillus Fumigatus; randomized controlled clinical trials

Additional relevant MeSH terms:

Cystic Fibrosis; Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Itraconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP3A Inhibitors