A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AeroVanc for the Treatment of Persistent Methicillin-Resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients (SAV005-04)
Clinical Trial Information
Trial Contact: Tilme, Linda; Parrimon, Yozandra
IRB No: 17.059.05
Protocol Abbrev: SAV005-04 AeroVanc
Principal Investigator: Luis Antonio Faverio, MD
Sub Investigators: Garcia, Daniel MD; Kessler, Cynthia; Sabogal, Carlos MD; Weatherly, Mark MD
Phase: Drug: Phase III
Age Group: Pediatric
Secondary Protocol No: SAV005-04
Applicable Disease Sites: Cystic Fibrosis, Pulmonary, CF, Respiratory, MRSA
Therapies Involved: Vancomycin
To evaluate the efficacy of AeroVanc in improving lung function of CF patients with persistent MRSA lung infection.
Subjects ≥ 6 years of age
Confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following:
a. Positive sweat chloride test (value ≥ 60 mEq/L),
b. Genotype with 2 mutations consistent with CF (ie, a mutation in each of the cystic fibrosis transmembrane conductance regulator [CFTR] genes).
3. Positive sputum culture or a throat swab culture for MRSA at Screening.