Hello, my name is Kat Quinn and I am the founder and CEO of the Blooming
Rose Foundation (BRF). Part of the mission of the BRF is to facilitate understanding
around new treatments options as well as current clinical trials for the cystic fibrosis
community.
Disclaimer: I am not affiliated with Savara Pharmaceuticals, nor am I receiving
compensation for composing the following information. I wrote this information based on
questions I have seen throughout social media sites, the information is correct to the
best of my knowledge. If you have more specific questions, please talk with a Savara
representative.
Savara Pharmaceuticals’ lead product candidate is AeroVanc™ (vancomycin
hydrochloride inhalation powder), the first inhaled antibiotic being developed to address
the growing population of MRSA-infected cystic fibrosis patients. By delivering
vancomycin directly to the site of infection, AeroVanc has the ability to improve clinical
efficacy and reduce adverse effects caused by broad-spectrum antibiotics.
A new phase II trial is currently recruiting cystic fibrosis (CF) patients with
persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection to
determine the effectiveness, safety, and pharmacokinetics of a new investigational
inhalable powder formulation of vancomycin called AeroVanc.
Contact Information
Website: www.aerovanc.com
Inquiry Form: http://aerovanc.com/contact-us/
Toll Free: (888) 302-4876
Telephone: (512 961-1891
Facebook: https://www.facebook.com/aerovanc
Twitter: https://twitter.com/SavaraPharma
Frequently Asked Questions
Q: What is Aero Vanc?
A: AeroVanc is a dry powder form of vancomycin in a capsule based inhaler.
Q:What are the FEV1 requirements?
A: FEV1 must be greater than 30 and less than 100
Q: What are the specific eligibility requirements?
A: http://aerovanc.com/about-trial
Q: What if I do not have insurance, but want to participate?
A: Insurance is not required for trial participation
Q: If a patient is allergic to Vancomycin IV’s will they also be allergic to AeroVanc?
A: An allergy to vancomycin would prevent study participation unless it is just isolated
red man syndrome
Q: How long is the trial?
A: The trial is approximately three months long
Q: How many site visits will be required over the course of the trial?
A: Approximately seven visits during the three month period
Q: If I/my child qualify for the study but do not live near a trial location can we still
participate?
A: Absolutely, you can receive a referral through your clinic to the closest participating
clinic.
Q: Will my clinic be supportive of our choice to use another clinic for the study?
A: Savara offers a referral program- if a clinic refers a patient to a participating clinic,
the clinic will be paid for the referral.
Q: We will need to travel to the trial site- will we be reimbursed?
A: Absolutely, not only will Savara reimburse travel, they will organize a driver for pick
up and drop off if needed.
Q: Will I receive any compensation for my time and efforts?
A: Yes, Savara is paying the qualified participants for their time.
Trial Locations
Alabama
Pulmonary Associates of Mobile
6701 Airport Boulevard, Suite B-131
Mobile, AL
United States, 36608
Investigator: Lawrence Sindel, MD
Study Coordinator: Michele Hemphill
Phone: (251) 631-3023
mhemphill@lungmds.com
Arkansas
University of Arkansas
Little Rock, AK
Investigator: Paula Anderson, MD
Not Yet Enrolling
California
Children's Hospital Los Angeles
Los Angeles, California
Investigator: Natalie Shilo , MD
Not Yet Enrolling
University of Southern California
Los Angeles, CA
Investigator: Dr. Adupa Rao
Not Yet Enrolling
University of California San Diego
La Jolla, California
Investigator: Kevin Shaw, MD
Not Yet Enrolling
Colorado
National Jewish Health
1400 Jackson Street
Denver, CO
United States, 80206
Investigator: David Nichols, MD
Study Coordinator: Connie St. Clair
Phone: 303-270-2517
StClairC@njhealth.org
Florida
University of Miami School of Medicine
Rosenstiel Medical Science Building
1600 N.W. 10th Ave., 7064-A, Locator Code R 47
Miami, FL
United States, 33136
Investigator: Dr. Matthias Salathe
Study Coordinator: Carolina Aguiar
Phone: 305-243-5545
caguiar2@med.miami.edu
Nemours Children's Clinic Research
1717 South Orange Ave., Suite 100
Orlando, FL
United States, 32806
Investigator: Dr. Floyd Livingston Jr.
Study Coordinator: Angela Price
Phone: (407) 650-7634
alprice@nemours.org
Central Florida Pulmonary Group
1115 East Ridgewood Street
Orlando, FL
United States, 32803
Investigator: Daniel Layish, MD
Study Coordinator: Kenneth (Bert) Kesser
Phone: (407) 841-1100 ext.227
bkesser@cfpulmonary.com
University of Miami School of Medicine
Rosenstiel Medical Science Building
1600 N.W. 10th Ave., 7064-A, Locator Code R 47
Miami, FL
United States, 33136
Investigator: Dr. Matthias Salathe
Study Coordinator: Carolina Aguiar
Phone: 305-243-5545
caguiar2@med.miami.edu
Illinois
Chicago CF Care Specialists
2401 Ravine Way # 302
Glenview, IL
United States, 60025
Investigator: Dr. Steven Boas
Study Coordinator: Karen Acker
Phone: (847)998-3434
karen.j.acker@gmail.com
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Investigator: Adrienne Prestridge Savant, MD, MS
Not Yet Enrolling
Kansas
University of Kansas
3901 Rainbow Blvd
Kansas City, KS
United States, 66160
Investigator: Dr. Joel Mermis
Study Coordinator: Adam Schooley
Phone: 913-588-4022
aschooley@kumc.edu
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Investigator: Manu Jain, MD
Not Yet Enrolling
Kentucky
University of Louisville
Louisville, Kentucky
Investigator: Ronald L Morton , MD
Not Yet Enrolling
University of Kentucky
CF Center- Division of Pediatric Pulmonology
740 South Limestone, J410
Lexington, KY
United States, 40536
Investigator: Dr. Zoran Danov
Study Coordinator: Brittany Fuller
Phone: (859)257-9357
Brittany.fuller@uky.edu
Massachusetts
University of Massachusetts Worcester
Worcester, Massachusetts
Investigator: Brian O'Sullivan, MD
Not Yet Enrolling
Children's Hospital Boston
CF Center, Pulmonary Division
300 Longwood Ave. (Mailstop 208) Hunnewell 2
Boston, MA
United States, 02115
Investigator: Dr. Gregory Sawicki
Study Coordinator: Robert Fowler
Phone: (617)355-1834
robert.fowler@childrens.harvard.edu
Massachusetts General Hospital
CF Center, Professional Office Building Suite 540
275 Cambridge St., Suite 530
Boston, MA
United States, 02114
Investigator: Dr. Samuel Moskowitz
Study Coordinator: Caitlin Doolittle
Phone: (617) 726-3719
cdoolittle1@partners.org
Michigan
Wayne State University, Harper Hospital, Children's Hospital of Michigan
Detroit, MI
Investigator: Dana G. Kissner, M.D.
Not Yet Enrolling
Missouri
Washington University
660 South Euclid Avenue
Campus box 8116
St. Louis, MO
United States, 63110
Investigator: Dr. Jeff Atkinson
Study Coordinator: Denise Rodgers
Phone: (314)286-1176
Rodgers@kids.wustl.edu
New York
Columbia University Medical Center
622 W. 168th St.
PH8, Room 859
New York, NY
United States, 10032
Investigator: Dr. Emily DiMango
Study Coordinator: Surinder (Sumit) Narula
Phone: (212)305-0251
Sn2027@Columbia.edu
Hofstra North Shore – Long Island Jewish School of Medicine
Lake Success / Great Neck, NY
Investigator: Rubin Cohen, MD
Not Yet Enrolling
North Carolina
University of North Carolina @ Chapel Hill
450 MacNider Bldg. CB#7217
333 S. Columbia St.
Chapel Hill, NC
United States, 27599
Investigator: Dr. George Retsch-Bogart
Study Coordinator: Kelly Stephenson
Phone: (919)843-7121
Kelly.stephenson@unc.edu
Duke University
Durham, NC
Investigator: Deanna Green, MD MHS
Not Yet Enrolling
Ohio
Dayton Children's Medical Center
The Children's Medical Center of Dayton
One Childrens's Plaza
Dayton, OH
United States, 45404
Investigator: Dr. Robert Fink
Study Coordinator: Sandy Bartosik
Phone: (937)-641-4004
bartosiks@childrensdayton.org
Nationwide Children's Hospital
Section of Pulmonary Medicine
700 Children's Dr.
Columbus, OH
United States, 43205
Investigator: Dr. Karen McCoy
Study Coordinator: Laura Raterman
Phone: (614)722-4758
Laura.raterman@nationwidechildrens.org
University Hospital Case Medical Center
11100 Euclid Ave
Cleveland, OH
United States, 44106-6006
Investigator: Dr. Elliott Dasenbrook
Study Coordinator: Roberta (Bobbi) Ksenich
Phone: 216-844-5733
Roberta.Ksenich@UHhospitals.org
Oklahoma
Dr. Santiago Reyes, P.C.
3366 NW Expressway, Bld D, Suite 330
Oklahoma City, OK
United States, 73112
Investigator: Dr. Santiago Reyes
Study Coordinator: Teresa Orf
Phone: (405)945-4495
sreyespedpulm@coxinet.net
Pennsylvania
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey
United States 08901
Investigator: Sabiha Hussain, MD
Study Coordinator: Deborah A McCloskey, RN, BSN
Phone: 732-418-8478
mcclosda@rwjms.rutgers.edu
Children's Hospital of Pittsburgh of UPMCU
Pulmonary Medicine, Allergy and Immunology
One Children's Hospital Dr.,4401 Penn Ave.AOB Suite 3300
Pittsburgh, PA
United States, 15224
Investigator: Dr. Jonathan Spahr
Study Coordinator: Sandy Hurban
Phone: (412) 692-7042
sandra.hurban@chp.edu
University of Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, PA
Investigator: Denis Hadjiliadis MD, MHS, FRCP(C)
Not Yet Enrolling
South Carolina
Medical University of South Carolina (MUSC)
96 Jonathan Lucas St. Suite 812 CSB, MSC 630
Charleston, SC
United States, 29425
Investigator: Dr. Patrick Flume
Study Coordinator: Lisa Miller
Phone: (843)792-5168
milll@musc.edu
Tennessee
Vanderbilt University
Nashville, TN
Investigator: Elisabeth Willers, MD
Not Yet Enrolling
Texas
University of Texas Southwestern Medical Center
Dallas, TX
Investigator: Raksha Jain, MD
Not Yet Enrolling
University of Texas Health Center at Tyler
11937 US Hwy 271
Tyler, TX
United States, 75708-3154
Investigator: Dr. Rodolfo Amaro
Study Coordinator: Rebekah Hibbard
Phone: (903)877-8246
Rebekah.Hibbard@uthct.edu
Austin Children's Chest Associates
1301 Barbara Jordan Blvd., Suite 303
Austin, TX
United States, 78723
Investigator: Dr. Bennie McWilliams
Study Coordinator: Leanne Struck
Phone: 512-380-9200 ext 205
lmstruck@seton.org
Texas Children's Hospital
6701 Fannin, Suite # 1040
Houston, TX
United States, 77030
Investigator: Dr. Siby Moonnumakal
Study Coordinator: Nicoline Schaap
Phone: (832)822-4252
nxschaap@texaschildrens.org
Utah
University of Utah Health Sciences Center
50 North Medical Drive, 701 Wintrobe 26 North 1900 East
Salt Lake City, UT
United States, 84132
Investigator: Dr. Ted Liou
Study Coordinator: Kristyn Packer
Phone: (801) 585-0401
kristyn.packer@hsc.utah.edu
Washington
University of Washington Medical Center
1959 NE Pacific St.
BB-1361 HSB Box 356522
Seattle, WA
United States, 98195
Investigator: Dr. Moira Aitken
Study Coordinator: Genecelle Delossantos
Phone: (206) 779-9496
gen7@uw.edu