Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex
Recruitment status was Active, not recruiting
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, treatment options are often limited. New therapies to improve outcomes for patients infected with BCC are needed.
However, because of the unpredictable nature of this pulmonary infection in CF, patients with BCC infection have been excluded from many CF therapeutic trials.
Recent published trials in the United States, Australia, and the United Kingdom have all demonstrated clinical benefits from prolonged administration of azithromycin in CF. In these trials, the vast majority of patients were chronically infected with Pseudomonas aeruginosa.
Patients with BCC were excluded from the US and UK trials, and only four patients with BCC infection were enrolled in the Australian trial. Thus, the effectiveness of azithromycin in CF patients infected with BCC is largely unknown and deserves further study.
The two main ways by which azithromycin is thought to help with the chronic lung infections seen in CF are by [a] reducing inflammation and [b] direct effects on the bacteria, in particular P. aeruginosa. BCC pulmonary infection in CF is often associated with a large inflammatory response similar to or more severe than P. aeruginosa infection. If azithromycin works mainly by an anti-inflammatory mechanism, it should also be helpful in CF patients infected with BCC.
Alternatively, azithromycin could have a direct effect on BCC as seen with P. aeruginosa as the two bacteria have many similarities.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Azithromycin in Patients With CF, Chronically Infected With Burkholderia Cepacia Complex|
- Change in FEV1 in % predicted in CF study subjects treated with azithromycin compared with those CF study subjects treated with placebo. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||October 2009|
|Estimated Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Azithromycin
participants taking 500 mg tablets orally thrice weekly for 24 weeks
500 mg tablets orally thrice weekly for 24 weeks
Placebo Comparator: Placebo
Participants taking 500 mg tablets orally thrice weekly for 24 weeks
tablet orally thrice weekly for 24 weeks
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298922
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B1W8|
|Principal Investigator:||Elizabeth Tullis, MD||University of Toronto|