drugset / Trial / NCT03181932

AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis

NCT03181932 ↗

Phase 3 Completed 188 enrolled Savara Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2017-09-20
Primary completion
2020-07-28
Completion
2021-01-15

Outcome

Missed primary endpoint

registry p = 0.325; Least square mean difference 1.4 (95% CI -1.4 to 4.1) NCT03181932 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vancomycin Other / unclassified 30 mg Inhaled