Page Title
Clinical Trial Finder
Anti-Infective Completed with Results
AeroVanc for the treatment of MRSA in people with CF (Savara SAV005-02)
This study evaluated the safety and effectiveness of AeroVanc in treating persistent MRSA lung infections in people with cystic fibrosis.
Participants were randomly assigned to receive twice daily AeroVanc (32mg or 64mg) or twice daily placebo for 28 days. Participants that also had Pseudomonas aeruginosa (Pa) co-infection were allowed to stay on their Pa treatment regimen. Participants who took their Pa treatment on a daily basis, but every other month, received AeroVanc or placebo in their off month. Participants who took their Pa treatment daily every month, received AeroVanc or placebo in the month where they typically used a Pa treatment other than TOBI.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30 to 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible subjects must be chronically infected with MRSA
Study Results
-
What We Learned:
This study found that at 64 mg, AeroVanc resulted in a statistically significant reduction in MRSA sputum density when compared with placebo (-0.63 Log10 CFU/mL versus 0.16 Log10 CFU/mL). Overall, AeroVanc was well tolerated. However, at the 64mg dose, more participants receiving AeroVanc experienced increased symptoms consistent with bronchoconstriction than placebo.
-
Primary Findings:
Effectiveness:
This study was conducted between March 2013 and November 2014. In the 32mg group, 16 participants receiving AeroVanc and 16 participants receiving placebo completed the study. In the 64mg group, 11 participants receiving AeroVanc and 15 receiving placebo completed the study.
The primary objective of the study was the change in MRSA sputum density from baseline to day 29. This study met its primary objective.
At the 64mg dose, there was a statistically significant reduction in MRSA sputum density (-0.63 Log10 CFU/mL (0.232)) when compared with placebo (0.16 Log10 CFU/mL (0.201)). The change in MRSA sputum density at 32mg AeroVanc group was -0.25 Log10 CFU/mL (0.181) compared with -0.30 Log10 CFU/mL (0.182) in the placebo group.
Improvement in the Cystic Fibrosis Respiratory Symptom Diary (CFRSD) Chronic Respiratory Infection Symptom Scores (CRISS) was seen in the 32mg AeroVanc group when compared with placebo (-6.59 versus -3.02, respectively).
Safety:
Overall, AeroVanc was well tolerated. However, at the 64mg dose, more participants receiving AeroVanc experienced increased symptoms consistent with bronchoconstriction than placebo.
These results have been provided by Clinicaltrials.gov and a Savara Pharmaceuticals Press Release and have not been peer reviewed.
-
Citation:
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
16 weeks -
Number of Study Visits:
9
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Savara -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30 to 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible subjects must be chronically infected with MRSA

CONTACT THE CLINICAL TRIAL NAVIGATOR
Get personalized assistance and answers to your clinical trial questions.
Learn MoreSign up for clinical trial alerts
Get email updates about clinical trials that matter to you.
Check the Drug Development Pipeline
We’re attacking CF from every angle. Learn about the status of CF drugs in development.
Learn More