Cystic Fibrosis MRSA Lung-Infection Treatment with AeroVanc – Phase III

Protocol Description

The purpose of this multicenter study is to determine if a new powder form of the antibiotic vancomycin, known by the trade name AeroVanc, can be used with a reloadable capsule inhaler for treatment of a chronic methicillin-resistant Staphylococcus aureus (MRSA) lung infection in patients with cystic fibrosis. The conventional administration of vancomycin is intravenous injection. Through this study, researchers will be comparing effectiveness of the inhaler version.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to participants of both genders, ages 6 years and older, who have cystic fibrosis and a chronic MRSA lung infection.
Males and females: Ages 6 years and older

Requirements

There are two parts to the study. In the first part, half the participants will use the study medication twice a day for 4 weeks days, and half will use a placebo, although these will be randomly assigned and participants will not know which they are taking. For the next 4 weeks, no study medication (or placebo) will be taken, completing the first cycle. The cycle repeats two more times for a total of 24 weeks. Upon completion of part 1, everyone continuing in the study will receive the study medication for 4 weeks, followed by no treatment for 4 weeks, repeating the cycle for a total of 24 weeks. Throughout the course of the study, participants will be seen by the research team for physicals and various tests up to 13 times.
Visits: 13
Duration: 54 weeks

Status: Open to Enrollment

Source(s) of Support

Savara

Additional Information

Study Description at National Institutes of Health
Cystic Fibrosis
Pulmonary Medicine Research

Primary Investigator

Mark Dovey, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Nurse Coordinator
Rose Lanzo BS, RRT, CRC
412-692-5872