Study of AeroVanc for the Treatment of Persistent MRSA in CF

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)

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Tilme, Linda; Parrimon, Yozandra

    Trial Phone: 321.843.5278 ; 321.841.1361

  • 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

    Treatment: Medication

    Applicable Disease Sites: Cystic Fibrosis, Pulmonary, CF, Respiratory, MRSA

    Therapies Involved: Vancomycin

  • Objective

    To evaluate the efficacy of AeroVanc in improving lung function of CF patients with persistent MRSA lung infection.

  • Key Eligibility

    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.