The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in
Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that
persistent infection with MRSA may result in an increased rate of decline in Forced
Expiratory Volume (FEV)1 and shortened survival. Currently there are no conclusive studies
demonstrating an effective aggressive treatment protocol for persistent MRSA respiratory
infection in CF. Data demonstrating an effective and safe method of clearing persistent MRSA
infection are needed.
The purpose of this study is to evaluate the safety and efficacy of a 28-day course of
vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in
eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA
infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250
mg twice a day) or taste matched placebo and will be followed for 3 additional months. In
addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or
doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes.
Forty patients with persistent respiratory tract MRSA infection will be enrolled in this
trial.
Phase:
Phase 2
Details
Lead Sponsor:
Johns Hopkins University Michael Boyle
Collaborators:
Case Western Reserve University Cystic Fibrosis Foundation Cystic Fibrosis Foundation Therapeutics