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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 |
| 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 subjects not co-infected with P. aeruginosa and 127 days for those that are. |
| Age: |
>= 12 Years
|
| FEV1: |
30 - 90 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. |
| Sponsor Contact Information: |
|
| 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. |
| FL |
-
Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
Contact Information:
Kesser, Kenneth (Bert)
Phone: (407) 650-7175
Email: bkesser@nemours.org
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Tampa General Hospital (Adult), Tampa, FL, 33606
Contact Information:
Roberson, Suzanne
Phone: (813) 844-7179
Email: sroberson@tgh.org
|
| KY |
-
University of Kentucky (Pediatric), Lexington, KY, 40536
Contact Information:
Watts, Tammy
Phone: (859) 257-5087
Email: twatt2@uky.edu
|
| MA |
-
Massachusetts General Hospital (Pediatric), Boston, MA, 02114
Contact Information:
Doolittle, Caitlin
Phone: (617) 726-3719
Email: cdoolittle1@partners.org
|
| NC |
-
University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
Contact Information:
Stephenson, Kelly
Phone: (919) 843-7121
Email: kelly.stephenson@unc.edu
|
| NY |
-
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
|
| 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
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Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
Contact Information:
Johnson, Mary Terri
Phone: (614) 722-4766
Email: Terri.Johnson@nationwidechildrens.org
|
| PA |
-
Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
Contact Information:
Hartigan, Elizabeth
Phone: (412) 692-7060
Email: elizabeth.hartigan@chp.edu
|
| TX |
-
Dell Children's Medical Center of Central Texas (Pediatric and Adult), Austin, TX, 78723
Contact Information:
Brazil, Isolde
Phone: (512) 380-9200 X206
Email: IBrazil@accapa.com
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