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SAV005-04 "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

This is a study that will examine any benefits to use cycles of inhaled vancomycin compared to placebo. Analysis of the information will include lung function results, sputum or throat culture results, questionnaires, and time to use additional antibiotics up to 48 weeks. After the first 24 weeks, all subjects can receive open label study drug for the remaining 24 weeks. There are 13 study visits spanned over 48 weeks.
Diane Kitch at dkitch@pennstatehealth.psu.edu or 717-531-5646
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This study is NOT accepting healthy volunteers
NCT03181932
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Inclusion Criteria:
6 years old and greater
Must have Cystic Fibrosis (CF)
Positive culture for MRSA at screening
FEV1 between 30-90%
Commit to 14 visits over 12 months
Exclusion Criteria:
You may not have allergies to vancomycin
Abnormal liver or kidney function
Inability to tolerate inhaled products
Lung Disease & Asthma
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Location
Hershey, PA