At a glance
ClinicalIndex Comparison Record- ✓Age ≥6 years at time of informed consent
- ✓Confirmed CF diagnosis by sweat chloride test (≥60 mEq/L) or 2 CF-causing CFTR mutations
- ✓Persistent MRSA colonization: positive sputum or throat swab at Screening plus ≥2 prior positive cultures (one >6 months prior) with ≥50% of all MRSA cultures positive in past year
- ✓FEV1 between 30% and 90% of predicted (age, gender, race, height-adjusted per Global Lung Function Initiative)
- ✕Anti-MRSA maintenance therapy within 28 days (IV or inhaled) or 14 days (oral) prior to Baseline
- ✕Non-maintenance antibiotics for MRSA or pulmonary infection within 28 days (IV or inhaled) or 14 days (oral) prior to Baseline
- ✕History of allergy or sensitivity to vancomycin or other study drug components (except red-man syndrome)
- ✕Inability to tolerate inhaled products or short-acting beta-2 agonist
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Vancomycin inhalation powder and Placebo inhalation powder for MRSA and Cystic Fibrosis. Completed, enrolled 188 participants across 71 sites in 2 countries.
Detailed Summary
This is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis (CF).
Study Details
Timeline
Interventions
100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \>21 years old) for 24 weeks during Period 1.
100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \>21 years old) for 24 weeks during Period 1.
In the 24-week Period 2, all participants are to be treated with open-label vancomycin inhalation powder.