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



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:6 - Any
Updated:4/6/2019
Start Date:September 26, 2017
End Date:September 30, 2020
Contact:Jessica Jackson
Email:jessica.jackson@savarapharma.com
Phone:832-231-6283

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

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.

Inclusion Criteria

1. Subjects ≥ 6 years of age at time of Informed Consent Form (ICF) or Assent Form
signing.

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

1. Positive sweat chloride test (value ≥ 60 mEq/L),

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

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

4. 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 more than 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)

5. Forced expiratory volume in 1 second (FEV1) ≥ 30% and ≤ 90% of predicted that is
normal for age, gender, race, and height, using the Global Lung Function Initiative
(GLI) equation.

6. 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).

7. 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:

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

2. 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.

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

4. 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.

5. Hysterectomy or surgical sterilization.

6. Abstinence.

7. 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.

8. 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.

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

10. Subjects with a P. 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.

Exclusion Criteria

1. Use of anti-MRSA treatments prescribed as maintenance therapy (intravenous [IV] or
inhaled treatment within 28 days; oral treatment within 14 days) prior to the Baseline
visit.

2. Use of non-maintenance antibiotic for pulmonary infection or extrapulmonary MRSA
infection (IV or inhaled antibiotic within 28 days; oral antibiotic within 14 days)
prior to the Baseline visit.

3. History of previous allergies or sensitivity to vancomycin, or other component(s) of
the study drug or placebo except for a history of red-man syndrome.

4. Inability to tolerate inhaled products.

5. First time sputum culture or throat swab culture yielding B. cepacia, or
nontuberculous Mycobacteria in the previous 6 months to Screening.

6. History of lung or other solid organ transplantation or currently on the list to
receive lung or other solid organ transplantation.

7. Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus
[VRSA], or vancomycin intermediate resistant Staphylococcus aureus [VISA], with
minimum inhibitory concentration [MIC] ≥ 8 μg/mL).

8. Oral corticosteroids in doses exceeding 10 mg prednisone per day or 20 mg prednisone
every other day, or equipotent doses of other corticosteroids.

9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid
medications within 14 days, or changes in CFTR modulators within 28 days, prior to the
Baseline visit.

10. Abnormal laboratory findings or other findings or medical history at Screening that,
in the Investigator's opinion, would compromise the safety of the subject or the
quality of the study data.

11. Inability to tolerate inhalation of a short acting beta2 agonist

12. SpO2 <90% at Screening.

13. Changes in physiotherapy technique or physiotherapy scheduled within 1 week of the
Baseline visit.

14. Administration of any investigational drug or device within 4 weeks prior to the
Screening visit and during the study

15. Female with positive pregnancy test result during Screening, pregnant (or intends to
become pregnant), lactating or intends to breastfeed during the study.

16. Renal insufficiency, defined as creatinine clearance < 50 mL/min using the
Cockcroft-Gault equation for adults or Schwartz equation for children at the Screening
visit.

17. Abnormal liver function, defined as ≥ 4x upper limit of normal (ULN), of serum
aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT), or known
cirrhosis at Screening.

18. Diagnosed with clinically significant hearing loss.

19. History of positive result for human immunodeficiency virus (HIV), hepatitis B virus
(HBV) or hepatitis C virus (HCV).

20. Planned hospitalizations for prophylaxis antibiotic treatment within 28 days prior to
Baseline visit or during the double-blind period (Period 1).
We found this trial at
77
sites
11100 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Ross Myers, MD
Phone: 216-844-8270
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Principal Investigator: Greg Omlor, MD
Phone: 330-543-3510
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Raouf Amin, MD
Phone: 513-803-4325
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Rajani Jagana, MD
Phone: 501-686-5527
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Thomas Keens, MD
Phone: 323-361-2972
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Principal Investigator: Laura Sass, MD
Phone: 757-668-8244
Children's Hospital of The King's Daughters Children
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326 North Mills Avenue
Orlando, Florida 32803
Principal Investigator: Daniel Layish, MD
Phone: 407-841-1100
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Michael Powers, MD
Phone: 503-494-6180
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Sacramento, California 95814
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Phone: 916-734-8686
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Donna Wiley-Courand, MD
Phone: 210-567-5262
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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Phone: 518-262-7851
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Albuquerque, New Mexico 87131
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Samya Nasr, MD
Phone: 734-615-3266
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Atlanta, Georgia 30342
Principal Investigator: Kevin Kirchner, MD
Phone: 404-785-3225
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Augusta, Georgia 30912
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Phone: 706-721-7699
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Edith Zemanick, MD
Phone: 720-777-4645
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Austin, Texas 78723
Principal Investigator: Bennie McWilliams, MD
Phone: 512-380-9200
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Gregory Sawicki, MD
Phone: 617-355-2446
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Charleston, South Carolina 29425
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Charlottesville, Virginia 22908
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Colchester, Vermont 05446
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Columbus, Ohio 43205
Principal Investigator: Karen McCoy, MD
Phone: 614-722-4758
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Dallas, Texas 75235
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Phone: 214-456-5489
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Dayton, Ohio 45404
Principal Investigator: Gary Mueller, MD
Phone: 937-641-4004
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Denver, Colorado 80206
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Phone: 303-270-2827
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Detroit, Michigan 48201
Principal Investigator: Ibrahim Abdulamid, MD
Phone: 313-745-4737
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Mai El Mallah, MD
Phone: 919-681-7391
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Fort Worth, Texas 76104
Principal Investigator: Karen Schultz, MD
Phone: 682-885-1244
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Gainesville, Florida 32610
Principal Investigator: Silvia Delgado, MD
Phone: 352-273-5417
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Glenview, Illinois 60025
Principal Investigator: Steven Boas, MD
Phone: 847-998-3434
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Hershey, Pennsylvania 17033
Principal Investigator: Gavin Graff, MD
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Hollywood, Florida
Principal Investigator: Herschel Scher, MD
Phone: 954-265-4466
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Michelle Mann, MD
Phone: 832-822-4772
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Indianapolis, Indiana 46202
Principal Investigator: Clement Ren, MD
Phone: 317-944-3380
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Iowa City, Iowa 52242
Principal Investigator: Richard Ahrens, MD
Phone: 319-384-7546
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Jacksonville, Florida 32207
Principal Investigator: David Schaeffer, MD
Phone: 904-697-3804
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Kansas City, Kansas
Principal Investigator: Joel Mermis, MD
Phone: 913-588-4020
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Kansas City, Missouri 64108
Principal Investigator: Hugo Escobar, MD
Phone: 816-458-4116
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Long Beach, California 90806
Principal Investigator: Cyrus Shahrairy, MD
Phone: 562-933-5607
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Los Angeles, California 90033
Principal Investigator: Adupa Rao, MD
Phone: 323-409-5383
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Louisville, Kentucky 40202
Principal Investigator: Ronald Morton, MD
Phone: 502-629-4695
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Memphis, Tennessee 38103
Principal Investigator: Patricia Dubin, MD
Phone: 901-287-6483
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Miami, Florida 33136
Principal Investigator: Andrew Colin, MD
Phone: 305-243-1425
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Miami, Florida 33136
Principal Investigator: Matthias Salathe, MD
Phone: 305-243-5545
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Nicholas Antos, MD
Phone: 414-337-7144
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Minneapolis, Minnesota 55404
Principal Investigator: Brooke Moore, MD
Phone: 612-813-7756
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Mobile, Alabama
Principal Investigator: Lawrence Sindel, MD
Phone: 251-631-3023
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Kathryn Moffett, MD
Phone: 304-293-5264
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Morristown, New Jersey 07962
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Morton Grove, Illinois 60053
Principal Investigator: Arvey Stone, MD
Phone: 847-738-7334
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New Brunswick, New Jersey 08903
Principal Investigator: Thomas Scanlin, MD
Phone: 732-235-5108
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New Hyde Park, New York 11042
Principal Investigator: Joan DeCelie-Germana, MD
Phone: 516-465-5400
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Emily DiMango, MD
Phone: 212-305-4675
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oklahoma City, Oklahoma 73112
Principal Investigator: Santiago Reyes, MD
Phone: 405-945-4495
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Oklahoma City, Oklahoma 73104
Principal Investigator: Nighat Mehdi, MD
Phone: 405-271-8001
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: John Colombo, MD
Phone: 402-708-2785
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Orlando, Florida 32806
Principal Investigator: Luis Faverio, MD
Phone: 321-841-7619
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13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Principal Investigator: Shatha Yousef, MD
Phone: 407-650-7964
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Daniel Dorgan, MD
Phone: 215-662-3115
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Gerald Gong, MD
Phone: 602-933-0343
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Pittsburgh, Pennsylvania 15224
Principal Investigator: Mark Dovey, MD
Phone: 412-692-5872
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Portland, Maine 04102
Principal Investigator: Colby Wyatt, MD
Phone: 207-662-6712
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Saint Louis, Missouri 63104
Principal Investigator: Gary Albers, MD
Phone: 314-678-5457
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Saint Louis, Missouri 63110
Principal Investigator: Jeff Atkinson, MD
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Saint Petersburg, Florida 33701
Principal Investigator: Deanna Green, MD
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Salt Lake City, Utah 84132
Principal Investigator: Ted Liou, MD
Phone: 801-587-7458
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San Antonio, Texas 78229
Principal Investigator: Donna Willey-Courand, MD
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San Diego, California 92093
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Ronald Gibson, MD
Phone: 206-987-3921
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Sioux Falls, South Dakota 57117
Principal Investigator: Chuanpit Moser, MD
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Toledo, Ohio 43606
Principal Investigator: Bruce Barnett, MD
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Tyler, Texas 75708
Principal Investigator: Rodolfo Amaro-Galvez, MD
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Vancouver, British Columbia
Principal Investigator: Mark Chilvers, MD
Phone: 604-875-2345
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707 North Emporia Avenue
Wichita, Kansas 67214
Principal Investigator: Natalie Sollo, MD
Phone: 316-268-6009
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Winston-Salem, North Carolina 27157
Principal Investigator: Victor Ortega, MD
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