• A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus aureus Lung Infection in Cystic Fibrosis Patients
Inhaled Vancomycin (AeroVanc) or placebo in Cystic Fibrosis patients 12 years and older with persistent MRSA infection of the lungs

The purpose of this research study is to see if an experimental drug called AeroVanc is safe to take and can help people with cystic fibrosis and persistent MRSA infections of the lungs. This study uses a placebo, which looks like AeroVanc, but does not contain any medicine.

The study consists of 8 study visits at Massachusetts General Hospital over a 14 week period. Each study visit involves:
• Lab work (sputum, urine and blood tests)
• PFTs (pulmonary function tests or spirometry)

Some, but not all, study visits also involve:
• ECG (electrocardiogram)
• Chest x-ray

Participants are assigned by chance to take for 28 days:
• AeroVanc, or
• Placebo

We are looking for cystic fibrosis patients who:
• Are 12 years old or older
• Have had MRSA in their sputum at least twice in the past year
• Have had a pulmonary exacerbation in the past 6 months
• Are willing and able to use an inhaler that we provide
• Are not pregnant or planning to become pregnant in the next 6 months
• Are willing to attend all study visits and perform all study procedures and tests

Participants will be paid up to $800 for completing the study. Out of pocket expenses can be reimbursed. The study drug is being provided at no cost to you.

For more information, contact Caitlin Doolittle at cdoolittle1@partners.org or 617-726-3719.
Institution  –  MGH - Massachusetts General Hospital, Boston, MA
Principal Investigator  – Samuel Moskowitz, MD
  
Enrollment Information
For further information about enrolling a patient in this trial, contact the person below.
Name  – Caitlin Doolittle
Phone  – 617-726-3719