Status:
UNKNOWN
Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Cystic Fibrosis Foundation
Pfizer
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
Pulmonary infection with Burkholderia cepacia complex (BCC) in patients with CF is often associated with a more rapid decline in lung function. Because of the resistance of BCC to many antibiotics, tr...
Detailed Description
STUDY DESIGN * Overview * This is a single center, randomized, double-blinded, placebo-controlled 24 week trial of azithromycin in adults with CF chronically infected with BCC. The investigational th...
Eligibility Criteria
Inclusion
- Informed consent and verbal assent as appropriate has been provided by the subject
- Ability to comply with medication use, study visits and study procedures as judged by the site Investigator
- Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
- \> 18 years of age
- Body weight \> 40 kg
- BCC present in a sputum/throat culture \> 1 year prior to screening and at screening
- FEV1 % predicted \> 30% as calculated by the Knudsen reference equations
- Room air oximetry \> 88% at rest
- Post-menarche females must be surgically sterile or using an effective form of contraception
- Predicted to live \> 1 year and clinically stable at that time of enrollment as judged by the investigator.
Exclusion
- History of chronic macrolide use, defined as regular macrolide antibiotic use within a three month period prior to enrollment in the study.
- AST or ALT \> 2.5 times the upper limit of normal performed at the local laboratories on two occasions prior to randomization.
- Investigational drug use within 30 days of screening
- History of alcohol, illicit drug or medication abuse within 1 year of screening
- Use of intravenous antibiotics or oral antibiotics within 14 days of screening.
- Use of low dose oral antibiotics (e.g. macrolides, tetracycline, sulfa) for acne or other conditions within 30 days of screening
- Use of systemic corticosteroids (\> 20 mg of prednisone per day) within 30 days of screening
- Initiation of TOBI®, high dose ibuprofen, or rhDNase within 60 days of screening
- History of lung transplantation or currently on lung transplant list
- History of allergy to a macrolide antibiotic
- AFB smear positive at screening suggesting current NTM infection.
- Positive serum pregnancy test at screening (to be performed on all post-menarche females)
- Absolute neutrophil count \< 1000 performed at the local laboratories on two occasions prior to randomization
- Creatinine \> 1.5 times normal performed at the local laboratories on two occasions prior to randomization.
- Chest x-ray changes or physical findings at screening that would compromise the safety of the patient or the quality of the study data
- Other major organ dysfunction
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00298922
Start Date
February 1 2006
End Date
October 1 2009
Last Update
July 31 2009
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8