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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181932
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Savara Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
MRSA Cystic Fibrosis Drug: Vancomycin inhalation powder Drug: Placebo inhalation powder Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : September 30, 2020


Arm Intervention/treatment
Experimental: Vancomycin inhalation powder
30 mg twice daily (BID)
Drug: Vancomycin inhalation powder
There will be 200 patients treated with Vancomycin inhalation powder or placebo (1:1 active to placebo). 150 subjects ≤21 years old, 50 subjects >21 years old.
Other Name: AeroVanc

Placebo Comparator: Placebo inhalation powder
Matching placebo inhaled twice daily (BID)
Drug: Placebo inhalation powder
There will be 200 patients treated with Vancomycin inhalation powder or placebo (1:1 active to placebo). 150 subjects ≤21 years old, 50 subjects >21 years old.




Primary Outcome Measures :
  1. Absolute change in FEV1 percent predicted [ Time Frame: Week 4, 12 and 20 ]
    The mean absolute change from baseline in FEV1 percent predicted; analyzed sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2), and at Week 20 (end of Cycle 3).


Secondary Outcome Measures :
  1. Time to first pulmonary exacerbation [ Time Frame: Week 4, 12 and 20 ]
    Time to first pulmonary exacerbation requiring use of another antibiotic medication (oral, IV, and/or inhaled)

  2. Frequency of pulmonary exacerbations [ Time Frame: Week 20 ]
    The number of pulmonary exacerbations during Period 1 adjusted for the length of follow-up

  3. Cystic Fibrosis Questionnaire-Revised (CFQ-R) scores [ Time Frame: Week 4, 12, and 20 ]
    Change from Baseline in the CFQ-R respiratory domain. Scores range between 0 and 100, where higher scores indicate a better outcome.

  4. Cystic Fibrosis Respiratory Symptom Diary-Chronic Respiratory Symptom Score (CFRSD-CRISS) scores [ Time Frame: Week 4, 12 and 20 ]
    Change from Baseline in the CFRSD-CRISS scores. Scores range between 0 and 100, where higher scores indicate a worse outcome.

  5. Relative change in FEV1 percent predicted [ Time Frame: Week 4, 12 and 20 ]
    The mean relative change from Baseline in FEV1 percent predicted

  6. Number of successful response cycles [ Time Frame: Week 4, 12 and 20 ]
    The number of successful response cycles a subject achieves over Period 1. A response in a cycle is defined by at least a 5 % relative improvement in FEV1 percent predicted at the end of each the respective cycle.

  7. Area under the FEV1-time profile [ Time Frame: Week 20 ]
    The mean treatment difference in FEV1 across all post-baseline visits



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181932


Contacts
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Contact: Jessica Jackson 832-231-6283 jessica.jackson@savarapharma.com

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Locations
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United States, Alabama
Pulmonary Associates of Mobile Recruiting
Mobile, Alabama, United States, 36608
Contact: Liz Knight    251-631-3023    eknight@lungmds.com   
Principal Investigator: Lawrence Sindel, MD         
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Natalia Argel    602-933-0343    Nargel@phoenixchildrens.com   
Principal Investigator: Gerald Gong, MD         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kathleen Hicks    501-686-5527    hickskathleent@uams.edu   
Principal Investigator: Rajani Jagana, MD         
United States, California
Miller Childrens Hospital MemorialCare Health System Pediatric Pulmonology Recruiting
Long Beach, California, United States, 90806
Contact: Candice Evans    562-933-5607    cevans@memorialcare.org   
Principal Investigator: Cyrus Shahrairy, MD         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Elizabeth Rowan    323-361-2972    erowan@chla.usc.edu   
Principal Investigator: Thomas Keens, MD         
University of Southern California Keck Medical Center of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Lynn Fukushima    323-409-5383    Lynn.fukushima@med.usc.edu   
Principal Investigator: Adupa Rao, MD         
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Brandt Robinson    916-734-8686    brrobinson@ucdavis.edu   
Principal Investigator: Brian Morrissey, MD         
University of California San Diego Withdrawn
San Diego, California, United States, 92103
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Mary Cross    720-777-4645    Mary.Cross@childrenscolorado.org   
Principal Investigator: Edith Zemanick, MD         
National Jewish Health Adult Cystic Fibrosis Center Recruiting
Denver, Colorado, United States, 80206
Contact: Connie St Clair    303-270-2827    stclair@njhealth.org   
Principal Investigator: Sherstin Lommatzch, MD         
United States, Florida
University of Florida Pediatrics Recruiting
Gainesville, Florida, United States, 32610
Contact: Dawn Baker    352-273-5417    bakerdj@peds.ufl.edu   
Principal Investigator: Silvia Delgado, MD         
Memorial Healthcare System Recruiting
Hollywood, Florida, United States, 33021
Contact: Norma Jean Barton    954-265-4466    nbarton@mhs.net   
Principal Investigator: Herschel Scher, MD         
Nemours Childrens Specialty Care Recruiting
Jacksonville, Florida, United States, 32207
Contact: Betty DeLuca    904-697-3804    Elizabeth.deluca@nemours.org   
Principal Investigator: David Schaeffer, MD         
University of Miami Bachelor Children's Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Alejandra Weisman    305-243-1425    a.weisman1@miami.edu   
Principal Investigator: Andrew Colin, MD         
University of Miami School of Medicine Hospital Doctor's Office West Withdrawn
Miami, Florida, United States, 33136
Central Florida Pulmonary Group Recruiting
Orlando, Florida, United States, 32803
Contact: Kenneth Kesser    407-841-1100 ext 118    bkesser@cfpulmonary.com   
Principal Investigator: Daniel Layish, MD         
Arnold Palmer Hospital Pulmonary and Sleep Medical Institute Orlando Health, Inc Recruiting
Orlando, Florida, United States, 32806
Contact: Yajira Beltram    321-841-7619    Yajira.Beltran@orlandohealth.com   
Principal Investigator: Luis Faverio, MD         
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Germaine Wezel    407-650-7964    Germaine.wezel@nemours.org   
Principal Investigator: Shatha Yousef, MD         
Nemours Children's Specialty Care Recruiting
Pensacola, Florida, United States, 32514
Contact: Rebecca Davis    850-473-4553    Rebecca.davis@nemours.org   
Principal Investigator: Okan Elidemir, MD         
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Diana Hodge    727-767-6881    Dhodge6@jhmi.edu   
Principal Investigator: Deanna Green, MD         
United States, Georgia
Children's Health Care of Atlanta at Scottish Rite Recruiting
Atlanta, Georgia, United States, 30342
Contact: Terri Eubanks    404-785-3225    terri.eubanks@choa.org   
Principal Investigator: Kevin Kirchner, MD         
Augusta Univ Cystic Fibrosis Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Heidi Stapp    706-721-7699    hstapp@augusta.edu   
Principal Investigator: Kathleen McKie, MD         
United States, Illinois
Chicago CF Care Specialists Recruiting
Glenview, Illinois, United States, 60025
Contact: Katherine McKeown    847-998-3434    katie@wecare4lungs.com   
Principal Investigator: Steven Boas, MD         
NorthSurburban Pulmonary Specialists Recruiting
Morton Grove, Illinois, United States, 60053
Contact: Suellen Moen    847-738-7334    suellen.moen@advocatehealth.com   
Principal Investigator: Arvey Stone, MD         
United States, Indiana
Riley Hospital for Children at Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lisa France    317-944-3380    lfrance@iupui.edu   
Principal Investigator: Clement Ren, MD         
United States, Iowa
University of Iowa Department of Pediatrics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Tyler Farber    319-384-7546    tyler-farber@uiowa.edu   
Principal Investigator: Richard Ahrens, MD         
United States, Kansas
University of Kansas Recruiting
Kansas City, Kansas, United States, 66160
Contact: Lawrence Scott    913-588-4020    lscott2@kumc.edu   
Principal Investigator: Joel Mermis, MD         
Via Christi Health Systems CF Clinic Recruiting
Wichita, Kansas, United States, 67214
Contact: Lisa Aragon    316-268-6009    Lisa.Aragon@ascension.org   
Principal Investigator: Natalie Sollo, MD         
United States, Kentucky
University of Louisville Kosair Charities Pediatric Clinical Research Unit Recruiting
Louisville, Kentucky, United States, 40202
Contact: Molly Harper, BA, CCRC    502-629-4695    mrharp02@louisville.edu   
Principal Investigator: Ronald Morton, MD         
United States, Maine
Maine Medical Partners Pediatric Specialty Care Recruiting
Portland, Maine, United States, 04102
Contact: Carrie Milliard    207-662-6712    millic@mmc.org   
Principal Investigator: Colby Wyatt, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elizabeth Carpino    617-355-2446    Elizabeth.carpino@childrens.harvard.edu   
Principal Investigator: Gregory Sawicki, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Dawn Kruse    734-615-3266    dmkruse@med.umich.edu   
Principal Investigator: Samya Nasr, MD         
Wayne State University (HUH) Recruiting
Detroit, Michigan, United States, 48201
Contact: Aleah Hall    313-745-4737    AHall@dmc.org   
Principal Investigator: Ibrahim Abdulamid, MD         
United States, Minnesota
Childrens Health Care Withdrawn
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Children's Mercy Recruiting
Kansas City, Missouri, United States, 64108
Contact: April Williams    816-458-4116    alwilliams1@cmh.edu   
Principal Investigator: Hugo Escobar, MD         
Cardinal Glennon Children's Hospital /Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Freda Branch    314-678-5457    freda.branch@health.slu.edu   
Principal Investigator: Gary Albers, MD         
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Irma Bauer    314-747-2940    irmabauer@wustl.edu   
Principal Investigator: Jeff Atkinson, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Toni Blazek    402-708-2785    tblazek@unmc.edu   
Principal Investigator: John Colombo, MD         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Deb Connolly    973-971-5138    nancy.martinez@atlantichealth.org   
Principal Investigator: Stanley Fiel, MD         
Rutgers-Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Fei Chen    732-235-5108    chenf2@rwjms.rutgers.edu   
Principal Investigator: Thomas Scanlin, MD         
United States, New Mexico
University of New Mexico Pediatric/Pulmonary Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Olivia Nunez    505-272-9898    odnunez@salud.unm.edu   
Principal Investigator: Hengameh Raissy, MD         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Anne Denero    518-262-7851    deneroa@mail.amc.edu   
Principal Investigator: Thomas Smith, MD         
Northwell Health, Div of Pulmonary, Critical Care & Sleep Medicine Recruiting
New Hyde Park, New York, United States, 11042
Contact: Stacy Jackson    516-465-5400    sjackson13@northwell.edu   
Principal Investigator: Joan DeCelie-Germana, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Amanda Kramer    212-305-4675    ark2187@columbia.edu   
Principal Investigator: Emily DiMango, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Heidi Tiedge    919-681-7391    heidi.tiedge@duke.edu   
Principal Investigator: Mai El Mallah, MD         
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kathryn Kennedy    336-713-8559    klkenned@wakehealth.edu   
Principal Investigator: Victor Ortega, MD         
United States, Ohio
Akron Children's Hospital Withdrawn
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Sharon Kadon    513-803-4325    Sharon.Kadon@cchmc.org   
Principal Investigator: Raouf Amin, MD         
University Hospital Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Brittany Hirth    216-844-8270    Brittany.Hirth@uhhospitals.org   
Principal Investigator: Ross Myers, MD         
The Research Institute at Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Laura Raterman    614-722-4758    laura.raterman@nationwidechildrens.org   
Principal Investigator: Karen McCoy, MD         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Sandy Bartosik    937-641-4004    bartosiks@childrensdayton.org   
Principal Investigator: Gary Mueller, MD         
Toledo Children's Hospital CF Center Recruiting
Toledo, Ohio, United States, 43606
Contact: Kelly Hoot    419-291-4630    Kelly.Hoot@promedica.org   
Principal Investigator: Bruce Barnett, MD         
United States, Oklahoma
University of Oklahoma Health Science Center - Pediatric Pulmonary & CF Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Ashley Sanders    405-271-8001 ext 43053    ashley-sanders@ouhsc.edu   
Principal Investigator: Nighat Mehdi, MD         
Dr. Santiago Reyes, P.C. Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Teresa Orf    405-945-4495    teresaorf@yahoo.com   
Principal Investigator: Santiago Reyes, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jenna Bucher    503-494-6180    bucherj@ohsu.edu   
Principal Investigator: Michael Powers, MD         
United States, Pennsylvania
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Diane Kitch    717-531-5646    dkitch@hmc.psu.edu   
Principal Investigator: Gavin Graff, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Victoria Fleck    215-662-3115    Victoria.fleck@uphs.upenn.edu   
Principal Investigator: Daniel Dorgan, MD         
Children's Hospital of Pittsburgh of UPMCU Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Rose Lanzo    412-692-5872    rose.lanzo@chp.edu   
Principal Investigator: Mark Dovey, MD         
United States, South Carolina
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Abbi Reed    843-792-1820    reedab@musc.edu   
Principal Investigator: Patrick Flume, MD         
United States, South Dakota
Sanford Childrens Specialty Clinic Recruiting
Sioux Falls, South Dakota, United States, 57105
Principal Investigator: Chuanpit Moser, MD         
United States, Tennessee
East Tennessee Childrens Hospital Withdrawn
Knoxville, Tennessee, United States, 37916
UTHSC Lebonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Cathy Horobetz    901-287-6483    chorobet@uthsc.edu   
Principal Investigator: Patricia Dubin, MD         
United States, Texas
Austin Children's Chest Associates Recruiting
Austin, Texas, United States, 78723
Contact: Colleen Millian    512-380-9200 ext 65343    CaMillian@ascension.org   
Principal Investigator: Bennie McWilliams, MD         
Children's Medical Center Cystic Fibrosis Clinic Recruiting
Dallas, Texas, United States, 75235
Contact: Daniyal Kamal    214-456-5489    Daniyal.Kamal@childrens.com   
Principal Investigator: Preeti Sharma, MD         
Cook Children Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Heather Urbanek    682-885-1244    Heather.urbanek@cookchildrens.org   
Principal Investigator: Karen Schultz, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ellen Edwards    832-822-4772    exedward@texaschildrens.org   
Principal Investigator: Michelle Mann, MD         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Robin Tragus    210-567-5262    tragus@uthscsa.edu   
Principal Investigator: Donna Wiley-Courand, MD         
UT Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Robin Tragus    210-567-5262    tragus@uthscsa.edu   
Principal Investigator: Donna Willey-Courand, MD         
The University of Texas Health Science Center at Tyler Recruiting
Tyler, Texas, United States, 75708
Contact: Lilly Dohanich    903-877-5435    Elizabeth.garza@uthct.edu   
Principal Investigator: Rodolfo Amaro-Galvez, MD         
United States, Utah
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jane Vroom    801-587-7458    Jane.vroom@hsc.utah.edu   
Principal Investigator: Ted Liou, MD         
United States, Vermont
University Vermont Medical Center Vermont Lung Center Recruiting
Colchester, Vermont, United States, 05446
Contact: Julie Sweet    802-847-7958    Julie.sweet@uvmhealth.org   
Principal Investigator: Charlotte Teneback, MD         
United States, Virginia
University of Virginia Health System, Cystic Fibrosis Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Christie L. Aderholt, RN, BSN    434-297-7773    cla6e@virginia.edu   
Principal Investigator: Deborah Froh, MD         
Childrens Hospital of The King's Daughters Withdrawn
Norfolk, Virginia, United States, 23507
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Sharon McNamara    206-987-3921    sharon.mcnamara@seattlechildrens.org   
Principal Investigator: Ronald Gibson, MD         
University of Washington Medical Center Withdrawn
Seattle, Washington, United States, 98195
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Tammy Clark, RN, BSN    304-293-5264    tclark@hsc.wvu.edu   
Principal Investigator: Kathryn Moffett, MD         
United States, Wisconsin
Childrens Hospital of Wisconsin Withdrawn
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Alam Lakhani    604-875-2345 ext 7606    alam.lakhani@cw.bc.ca   
Principal Investigator: Mark Chilvers, MD         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Nancy McDonald    416-813-7865    nancy.mcdonald@sickkids.ca   
Principal Investigator: Felix Ratjen, MD         
Sponsors and Collaborators
Savara Inc.
Investigators
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Principal Investigator: Patrick Flume, MD Medical University of South Carolina

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Responsible Party: Savara Inc.
ClinicalTrials.gov Identifier: NCT03181932     History of Changes
Other Study ID Numbers: SAV005-04
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents