Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex
Status:
Unknown status
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
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, 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.
Phase:
Phase 2
Details
Lead Sponsor:
St. Michael's Hospital, Toronto Unity Health Toronto
Collaborators:
Cystic Fibrosis Foundation Cystic Fibrosis Foundation Therapeutics Pfizer