Research

Antibiotics and Lung Function

A Study of Azithromycin in Subjects with Cystic Fibrosis Between 6 and 18 Years Old with a Negative Culture for Pseudomonas aeruginosa

Protocol Description

The primary purpose of this study is to investigate whether the antibiotic azithromycin changes lung function in cystic fibrosis (CF) patients who are not infected with Pseudomonas aeruginosa (Pa). Although aziithromycin is used as a treatment for CF patients with Pa, it does not kill the Pa bacteria. Scientists believe its effectiveness may be due a variety of other factors, which could make it an effective treatment for CF patients without Pa., resulting in better pulmonary function tests and general health. This study is enrolling about 300 people across the country with local participants being evaluated at the Pediatric Clinical and Translational Research Center at Children’s Hospital of Pittsburgh of UPMC.

Eligibility Criteria

CF patients between the ages of 6 and 18 years old, who are not infected with the Pa bacteria, are invited to participate in this study.
Boys: 6 to 18 years
Girls: 6 to 18 years

Requirements
Candidates will undergo initial screening to determine eligibility due to a negative culture. Through a randomized drawing, candidates will be given either azithromycin or a placebo to be taken 3 times a week for 24 weeks. Scheduled visits will include additional sputum samples and blood draws.
Visits: 5
Duration: 6 months

Status: Open for Enrollment

Source of Support
Cystic Fibrosis Foundation

Additional Resources
Cystic Fibrosis
Study Description at National Institutes of Health

Primary Investigator(s)
Jonathan Finder, MD