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

Status: Completed
Location: See all (71) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: No
View:

• Participants ≥6 years of age at time of informed consent form or assent form signing.

• Confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following:

• Positive sweat chloride test (value ≥60 milliequivalent/L),

• Genotype with 2 mutations consistent with CF (i.e., a mutation in each of the cystic fibrosis transmembrane conductance regulator genes).

• Positive sputum culture or a throat swab culture for MRSA at Screening.

• In addition to the Screening sample, have at least 2 prior sputum or throat swab cultures positive for MRSA, of which at least 1 sample is >6 months prior to Screening. At least 50% of all MRSA cultures (sputum or throat swab culture) collected from the time of the first positive culture (in the previous 1 year) must have tested positive for MRSA. (Note: Screening sample may count towards 50% positive count)

• FEV1 ≥30% and ≤90% of predicted that is normal for age, gender, race, and height, using the Global Lung Function Initiative equation.

• At least 1 episode of acute pulmonary infection treated with non-maintenance antibiotics within 12 months prior to the Baseline visit (initiation of treatment with intermittent inhaled anti-Pseudomonal therapy will not qualify as treatment with non-maintenance antibiotics).

• If female of childbearing potential, an acceptable method of contraception must be used during the study and must be combined with a negative pregnancy test obtained during Screening; sexually active male subjects of reproductive potential who are non-sterile (i.e., male who has not been sterilized by vasectomy for at least 6 months, and were not diagnosed with infertility through demonstration of azoospermia in a semen sample and/or absence of vas deferens through ultrasound) must be willing to use a barrier method of contraception, or their female partner must use an acceptable method of contraception, during the study.

• For purposes of this study, the Sponsor defines acceptable methods of contraception as:

• Oral birth control pills administered for at least 1 monthly cycle prior to administration of the study drug.

• A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle prior to the study drug administration but not beyond the 4th successive year following insertion.

• Intrauterine devices, inserted by a qualified clinician for at least 1 monthly cycle prior to study drug administration.

• Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1 monthly cycle prior to administration of the study drug and continuing through 1 month following study completion.

• Hysterectomy or surgical sterilization.

• Abstinence.

• Double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam).

• Note: For subjects prescribed Orkambi: Orkambi may substantially decrease hormonal contraceptive exposure, reducing the effectiveness and increasing the incidence of menstruation-associated adverse reactions. Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi.

• Able and willing to comply with the protocol, including availability for all scheduled study visits and able to perform all techniques necessary to use the AeroVanc inhaler and measure lung function.

• Agree not to smoke during any part of the clinical trial (Screening visit through end of study).

• Participants with a Pseudomonas aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the Investigator, stable despite the lack of such treatment.

Locations
United States
Alabama
Pulmonary Associates of Mobile
Mobile
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Arizona
Phoenix Children's Hospital
Phoenix
California
Miller Childrens Hospital MemorialCare Health System Pediatric Pulmonology
Long Beach
Children's Hospital Los Angeles
Los Angeles
University of Southern California Keck Medical Center of USC
Los Angeles
UC Davis Medical Center
Sacramento
Colorado
Children's Hospital Colorado
Aurora
National Jewish Health Adult Cystic Fibrosis Center
Denver
Washington, D.c.
Children's National Medical Center
Washington
Florida
University of Florida Pediatrics
Gainesville
Memorial Healthcare System
Hollywood
Nemours Childrens Specialty Care
Jacksonville
University of Miami Bachelor Children's Hospital
Miami
Arnold Palmer Hospital Pulmonary and Sleep Medical Institute Orlando Health, Inc
Orlando
Central Florida Pulmonary Group
Orlando
Nemours Children's Hospital
Orlando
Nemours Children's Specialty Care
Pensacola
Johns Hopkins All Children's Hospital
Saint Petersburg
Georgia
Children's Health Care of Atlanta at Scottish Rite
Atlanta
Augusta Univ Cystic Fibrosis Center
Augusta
Iowa
University of Iowa Department of Pediatrics
Iowa City
Illinois
Chicago CF Care Specialists
Glenview
NorthSurburban Pulmonary Specialists
Morton Grove
Indiana
Riley Hospital for Children at Indiana University Health
Indianapolis
Kansas
University of Kansas
Kansas City
Via Christi Health Systems CF Clinic
Wichita
Kentucky
University of Louisville Kosair Charities Pediatric Clinical Research Unit
Louisville
Massachusetts
Boston Children's Hospital
Boston
Maine
Maine Medical Partners Pediatric Specialty Care
Portland
Michigan
University of Michigan Health System
Ann Arbor
Wayne State University (HUH)
Detroit
Missouri
Children's Mercy
Kansas City
Cardinal Glennon Children's Hospital /Saint Louis University
Saint Louis
Washington University
Saint Louis
North Carolina
Levine Children's Hospital - Atrium Health
Charlotte
Duke University Medical Center
Durham
Wake Forest School of Medicine
Winston-salem
Nebraska
University of Nebraska Medical Center
Omaha
New Jersey
Morristown Medical Center
Morristown
Rutgers-Robert Wood Johnson Medical School
New Brunswick
New Mexico
University of New Mexico Pediatric/Pulmonary
Albuquerque
New York
Albany Medical College
Albany
Northwell Health, Div of Pulmonary, Critical Care & Sleep Medicine
New Hyde Park
Columbia University Medical Center
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
University Hospital Cleveland Medical Center
Cleveland
The Research Institute at Nationwide Children's Hospital
Columbus
Dayton Children's Hospital
Dayton
Toledo Children's Hospital CF Center
Toledo
Oklahoma
University of Oklahoma Health Science Center - Pediatric Pulmonary & CF Center
Oklahoma City
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Penn State Children's Hospital
Hershey
University of Pennsylvania
Philadelphia
Children's Hospital of Pittsburgh of UPMCU
Pittsburgh
South Carolina
Medical University of South Carolina (MUSC)
Charleston
South Dakota
Sanford Childrens Specialty Clinic
Sioux Falls
Tennessee
UTHSC Lebonheur Children's Hospital
Memphis
Texas
Austin Children's Chest Associates
Austin
Children's Medical Center Cystic Fibrosis Clinic
Dallas
Cook Children Medical Center
Fort Worth
Texas Children's Hospital
Houston
The University of Texas Health Science Center at Tyler
Tyler
Utah
University of Utah Health Sciences Center
Salt Lake City
Virginia
University of Virginia Health System, Cystic Fibrosis Center
Charlottesville
Vermont
University Vermont Medical Center Vermont Lung Center
Colchester
Washington
Seattle Children's Hospital
Seattle
Providence Medical Research Center
Spokane
West Virginia
West Virginia University
Morgantown
Other Locations
Canada
The Hospital for Sick Children
Toronto
British Columbia Children's Hospital
Vancouver
Time Frame
Start Date: September 20, 2017
Completion Date: January 15, 2021
Participants
Target number of participants: 188
Treatments
Experimental: Double-blind vancomycin inhalation powder
Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.
Placebo Comparator: Double-blind placebo inhalation powder
Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.
Experimental: Open-label vancomycin inhalation powder
In the 24-week Period 2, all participants receive AeroVanc 30 mg BID by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.
Sponsors
Leads: Savara Inc.

This content was sourced from clinicaltrials.gov

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