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Study Name: AeroVanc for the treatment of MRSA in people with CF
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Savara
Study Phase: 2
Recruitment Status: Recruiting Completed
Study Drug(s): Inhaled Vancomycin
Number of Participants Being Recruited: 80
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This is a Phase 2a randomized, multicenter, double-blind, placebo-controlled, parallel group study to examine the safety and effectiveness of AeroVanc in the treatment of persistent MRSA lung infection in people with CF 12 years and older. Participants will be randomized to receive Aerovanc two times a day or placebo. Specimens of blood, urine, and sputum will be taken throughout the study along with pulmonary lung function testing. The study may last up to 98 days for all subjects.
ELIGIBILITY
Age: >= 12 Years
FEV1: 30 - 100 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Eligible subjects must be chronically infected with MRSA
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01746095
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
AR
  • University of Arkansas for Medical Sciences (Adult), Little Rock, AR, 72205
    Contact Information:
        Taggart, Adam
        Phone: (501) 416-7019
        Email: agtaggart@uams.edu
CA
  • University of California San Diego -Thornton (Adult), La Jolla, CA, 92037
    Contact Information:
        Shaw, Kevin
        Phone: (858) 657-7119
        Email: kdshaw@ucsd.edu
  • Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
    Contact Information:
        Vajda, Natalie
        Phone: (323) 361-3255
        Email: nvajda@chla.usc.edu
CO
  • National Jewish Health (Adult), Denver, CO, 80206
    Contact Information:
        Jones, Marion
        Phone: (303) 398-1265
        Email: jonesm@njhealth.org
FL
  • University of Miami (Pediatric), Miami, FL, 33136
    Contact Information:
        Mendes, Eliana
        Phone: (305) 243-2568
        Email: emendes@med.miami.edu
  • Central Florida Pulmonary Group (Adult), Orlando, FL, 32803
    Contact Information:
        Kesser, Kenneth (Bert)
        Phone: (407) 841-1100 X118
        Email: bkesser@cfpulmonary.com
  • Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
    Contact Information:
        Price, Angela
        Phone: (407) 650-7634
        Email: alprice@nemours.org
  • Tampa General Hospital (Adult), Tampa, FL, 33606
    Contact Information:
        Roberson, Suzanne
        Phone: (813) 844-7179
        Email: sroberson@tgh.org
IL
  • Ann and Robert H. Lurie Children's Hospital of Chicago (Pediatric), Chicago, IL, 60611
    Contact Information:
        Singh, Noopur
        Phone: (312) 227-6861
        Email: nosingh@luriechildrens.org
  • Northwestern University (Adult), Chicago, IL, 60611
    Contact Information:
        Singh, Noopur
        Phone: (312) 227-6861
        Email: nosingh@luriechildrens.org
KS
  • University of Kansas Medical Center (Pediatric), Kansas City, KS, 66160
    Contact Information:
        Marriott, Lyndsay
        Phone: (913) 588-6364
        Email: lbettlach@kumc.edu
KY
  • University of Kentucky (Pediatric), Lexington, KY, 40536
    Contact Information:
        Watts, Tammy
        Phone: (859) 257-5087
        Email: Tammy.watts@uky.edu
MA
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Fowler, Robert
        Phone: (617) 355-1834
        Email: Robert.fowler@childrens.harvard.edu
  • Massachusetts General Hospital (Pediatric), Boston, MA, 02114
    Contact Information:
        Doolittle, Caitlin
        Phone: (617) 726-3719
        Email: cdoolittle1@partners.org
MI
  • Wayne State University Harper University Hospital (Adult), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
        Email: cvanwag@med.wayne.edu
MO
  • Washington University School of Medicine (Adult), St. Louis, MO, 63110
    Contact Information:
        Burks, Patricia
        Phone: (314) 454-5175
        Email: Burks_P@kids.wustl.edu
NC
  • University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
    Contact Information:
        Barlow, Carol
        Phone: (919) 966-9146
        Email: cbarlow@med.unc.edu
NJ
  • Bristol-Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital (Adult), New Brunswick, NJ, 09801
    Contact Information:
        McCloskey, Deborah
        Phone: (732) 418-8478
        Email: mcclosda@rwjms.rutgers.edu
NY
  • Long Island Jewish Medical Center Adult Program (Adult), New Hyde Park, NY, 11040
    Contact Information:
        Wann, Li-Chen
        Phone: (516) 712-9608
        Email: LCWann@nshs.edu
  • Children's Hospital of New York Columbia University (Pediatric), New York City, NY, 10032
    Contact Information:
        Kattan, Meyer
        Phone: (212) 305-5122
        Email: mk2833@columbia.edu
  • Children's Hospital of New York Columbia University (Pediatric), New York City, NY, 10032
    Contact Information:
        Sadeghi, Hossein
        Phone: (212) 305-5122
        Email: hs762@cumc.columbia.edu
OH
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
  • Dayton Children's Hospital (Pediatric), Dayton, OH, 45404
    Contact Information:
        Bartosik, Sandy
        Phone: (937) 641-4004
        Email: bartosiks@childrensdayton.org
  • Wright State University (Adult), Dayton, OH, 45404
    Contact Information:
        Bartosik, Sandy
        Phone: (937) 641-4004
        Email: bartosiks@childrensdayton.org
PA
  • University of Pennsylvania Hospital (Adult), Philadelphia, PA, 19104
    Contact Information:
        Kubrak, Christina
        Phone: (267) 426-5135
        Email: kubrak@email.chop.edu
  • Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
SC
  • Medical University of South Carolina (Adult), Charleston, SC, 29425
    Contact Information:
        Warden, Ashley
        Phone: (843) 792-4349
        Email: jonesash@musc.edu
TN
  • Vanderbilt University Medical Center (Adult), Nashville, TN, 37232
    Contact Information:
        Robinette, Michelle
        Phone: (615) 343-9025
        Email: michelle.robinette@vanderbilt.edu
TX
  • Dell Children's Medical Center of Central Texas (Pediatric and Adult), Austin, TX, 78723
    Contact Information:
        Brazil, Isolde
        Phone: (512) 380-9200 X65343
        Email: IBrazil@seton.org
  • Children's Medical Center of Dallas (Pediatric), Dallas, TX, 75235
    Contact Information:
        Hebert, Andrew
        Phone: (214) 456-5618
        Email: andrew.hebert@childrens.com
  • Baylor College of Medicine (Adult), Houston, TX, 77030
    Contact Information:
        Cumming, Suzanne
        Phone: (713) 798-2686
        Email: scumming@bcm.tmc.edu
UT
  • Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
    Contact Information:
        Vroom, Jane
        Phone: (801) 587-7458
        Email: jane.vroom@hsc.utah.edu
WA
  • University of Washington Medical Center (Adult), Seattle, WA, 98195
    Contact Information:
        Aitken, Moira
        Phone: (206) 543-3166
        Email: moira@u.washington.edu
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