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Study Name: Persistent Methicillan Resistant Staphylococcus Aureus (MRSA) Growth in Respiratory Culture
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Boyle, Michael

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: Other
Recruitment Status: Recruiting
Study Drug(s): Multiple systemic antibiotics
Number of Participants Being Recruited: 40
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The study will look at the safety and effectiveness of a 28 day-course of vancomycin for inhalation in getting rid of the bacteria, Methicillan Resistant Staphylococcus Aureus (MRSA), from the respiratory tract of people with CF who have persistent MRSA infections. Study participants will be randomly assigned to either the vancomycin for inhalation or placebo for inhalation. In addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Specimens of blood, sputum, and urine will be collected during the trial as well as pulmonary lung function testing.
ELIGIBILITY
Age: >= 12 Years
FEV1: >= 30 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Negative
Other Primary Eligibility Requirements:

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: Boyle, Michael
(410) 502-7044
mboyle@jhmi.edu
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01594827?term=mrsa+and+cystic+fibrosis&rank=2
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.
MD
  • Johns Hopkins Adult CF Program (Adult), Baltimore, MD, 21205
    Contact Information:
        Callahan, Karen
        Phone: (443) 287-8983
        Email: kcallah1@jhmi.edu
OH
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Adult), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
  • 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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