CFF - Early Treatment of New Onset of Methicillan Resistant Staphylococcus Aureus (MRSA) Growth in Respiratory Culture

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Clinical Research Information Sheet

Study Name:

Early Treatment of New Onset of Methicillan Resistant Staphylococcus Aureus (MRSA) Growth in Respiratory Culture

Study Type:

Interventional

Intervention Category:

Anti-Infective

Study Sponsor:

Muhlebach, Marianne

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.

Study Phase:

Recruitment Status:

Recruiting

Study Drug(s):

Multiple systemic antibiotics

Number of Participants Being Recruited:

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

Methicillan-resistant Staphylococcus aureus (MRSA) is one germ that can cause a lung infection in people with CF. MRSA is harder to treat than other forms of the germ Staphylococcus aureus. In both people with CF and people without CF, MRSA can make some people sick and other people can have the germ without getting sick. People with CF who grow MRSA in their respiratory culture for the first time will be randomly assigned to either an early eradication protocol group who will receive treatment because their culture is postive or to an observational group that will only receive treatment if respiratory symptoms occur (the current typical approach toward treatment of positive cultures for MRSA).

ELIGIBILITY

Age:	4 Years - 45 Years
FEV1:	>= 30 Percent Predicted
P. aeruginosa status:	Not applicable
B. cepacia status:	Not applicable
Other Primary Eligibility Requirements: Subjects must have first OR early MRSA colonization and MRSA at screening
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:

Hocevar-Trnka, Jasna
(206) 884-7527
jasna.hocevar-trnka@seattlechildrens.org

Trial Specific Link on ClinicalTrials.gov:

http://www.clinicaltrials.gov/ct2/show/NCT01349192?term=mrsa+and+cystic+fibrosis&rank=1

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.

The Children's Hospital/University of Alabama at Birmingham (Pediatric), Birmingham, AL, 35233
Contact Information:
    Hathorne, Heather
    Phone: (205) 638-9568
    Email: hhathorne@peds.uab.edu

Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
Contact Information:
    Pardee, Churee
    Phone: (720) 777-6162
    Email: chureeporn.pardee@childrenscolorado.org

University of Florida (Pediatric), Gainesville, FL, 32610
Contact Information:
    Baker, Dawn
    Phone: (352) 273-5417
    Email: bakerdj@peds.ufl.edu

University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
Contact Information:
    Kruse, Dawn
    Phone: (734) 615-3266
    Email: dmkruse@umich.edu

Children's Hospitals and Clinics (Pediatric), Minneapolis, MN, 55404
Contact Information:
    Johnson, Mahrya
    Phone: (612) 813-6384
    Email: mahrya.johnson@childrensmn.org

St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
    Rodgers, Denise
    Phone: (314) 286-1176
    Email: rodgers@kids.wustl.edu
St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
    Burks, Patricia
    Phone: (314) 454-5175
    Email: Burks_P@kids.wustl.edu

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

University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
Contact Information:
    Acquazzino, Diane
    Phone: (402) 559-6275
    Email: dracquaz@unmc.edu
University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
Contact Information:
    Telfer, Raquel
    Phone: (402) 559-6275
    Email: raquel.telfer@unmc.edu

Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
Contact Information:
    Duan, Lorrie
    Phone: (513) 636-7089
    Email: lorrie.duan@cchmc.org

University of Texas Southwestern Medical Center/ St. Paul University Hospital (Adult), Dallas, TX, 75390
Contact Information:
    Keller, Ashley
    Phone: (214) 648-2817
    Email: Ashley.Keller@UTSouthwestern.edu
University of Texas Southwestern Medical Center/ St. Paul University Hospital (Adult), Dallas, TX, 75390
Contact Information:
    Dunn-Richmond, Kate
    Phone: (214) 648-2817
    Email: Kate.dunn-richmond@utsouthwestern.edu
Cook Children's Medical Center (Pediatric), Fort Worth, TX, 76104
Contact Information:
    Morris, Trudy
    Phone: (682) 885-1244
    Email: Trudy.Morris@cookchildrens.org
Baylor College of Medicine (Pediatric), Houston, TX, 77030
Contact Information:
    Schaap, Nicoline
    Phone: (832) 822-4252
    Email: nxschaap@texaschildrens.org

Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
Contact Information:
    McNamara, Sharon
    Phone: (206) 987-3921 X1
    Email: sharon.mcnamara@seattlechildrens.org
University of Washington Medical Center (Adult), Seattle, WA, 98195
Contact Information:
    Wolfstone, Alycia
    Phone: (206) 685-3995
    Email: aewolf@u.washington.edu