Clinical trial NCT00528190: Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis
Official title: Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Aspergillus Fumigatus
randomized controlled clinical trials
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Canadian Cystic Fibrosis Foundation
name: The Physicians' Services Incorporated Foundation
First posted: 2007-09-12
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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\&lt; 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

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Shawn Aaron, The Ottawa Hospital-General Campus
state: Ontario
city: Toronto
country: Canada
facility: Felix Ratjen, The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: OHRI
name: Shawn Aaron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.