Last updated on April 2019

A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients

Brief description of study

This study is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent MRSA in patients with Cystic Fibrosis.

Detailed Study Description

This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, parallel-group study to examine the safety and efficacy of AeroVanc in the treatment of persistent Methicillin resistant Staphylococcus aureus (MRSA) lung infection in patients diagnosed with cystic fibrosis (CF). After the Screening period to confirm study eligibility, subjects will be randomly assigned in a blinded fashion to receive either AeroVanc 30 mg twice daily (BID), or placebo BID (1:1 active to placebo) by inhalation for 24 weeks or 3 dosing cycles (Period 1). Upon completion of Period 1, subjects will receive open-label AeroVanc 30 mg BID for an additional 24 weeks or 3 dosing cycles (Period 2), to evaluate long-term safety of AeroVanc. A dosing cycle is defined as 28 days of treatment followed by 28 days of observation.

Subjects on a 28-day cyclical on/off anti-Pseudomonal antibiotic regimen will enter the Screening period at a time such that the Baseline visit coincides with the end of their anti-Pseudomonas antibiotic cycle. Study drug will thereby be administered during the off-cycle, and subjects can then resume anti-Pseudomonal therapy during the 28-day observation period. Subjects continuing alternating anti-Pseudomonal therapy can continue their treatment during the study drug administration, and observation period.

The primary and secondary analyses will be conducted in subjects 21 years old. Subjects >21 years old will be analyzed separately as a supportive analysis.

Clinical Study Identifier: NCT03181932

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Phoenix Children's Hospital

Phoenix, AZ United States
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University of Kansas

Kansas City, KS United States
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Washington University

Saint Louis, MO United States
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Wake Forest School of Medicine

Winston-Salem, NC United States
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Memorial Healthcare System

Hollywood, FL United States
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Children's Health Care

Minneapolis, MN United States
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Children's Mercy

Kansas City, MO United States
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Chicago CF Care Specialists

Glenview, IL United States
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Nemours Children's Hospital

Orlando, FL United States
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Johns Hopkins All Children's Hospital

Saint Petersburg, FL United States
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University of Florida Pediatrics

Gainesville, FL United States
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Morristown Medical Center

Morristown, NJ United States
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Albany Medical College

Albany, NY United States
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Texas Children's Hospital

Houston, TX United States
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University of Pennsylvania

Philadelphia, PA United States
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West Virginia University

Morgantown, WV United States
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UC Davis Medical Center

Sacramento, CA United States
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Nemours Childrens Specialty Care

Jacksonville, FL United States
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Dr. Santiago Reyes, P.C.

Oklahoma City, OK United States
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East Tennessee Childrens Hosp

Knoxville, TN United States
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Cook Children Medical Center

Fort Worth, TX United States
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Seattle Childrens Hospital

Seattle, WA United States
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Recruitment Status: Open

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