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Study Name: Biomarker of Pulmonary Exacerbation in Patients with CF
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Sagel, Scott

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: Other
Recruitment Status: Trial Completed
Study Drug(s): Multiple systemic antibiotics
Number of Participants Being Recruited: 130
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
A biomarker is a biochemical or a substance in the body that can be used to measure disease activity or effects of treatment. There is a need to identify biomarkers in CF that can be used to more quickly evaluate potential new treatments. Pulmonary exacerbations provide a nice opportunity to define the effect of intravenous antibiotics on candidate biomarkers and to determine whether clinical improvements are related to changes in bloodstream biomarkers.
ELIGIBILITY
Age: >= 10 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Additional key eligibility criteria: Initiation of IV antibioic therapy for a clinially diagnosed acute pulomonary exacerbation.
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: Sagel, Scott
(720) 777-5546
scott.sagel@childrenscolorado.org
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00788359?term=sagel+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.
CO
  • Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
    Contact Information:
        Pardee, Churee
        Phone: (720) 777-6162
        Email: churee.pardee@childrenscolorado.org
  • National Jewish Health (Adult), Denver, CO, 80206
    Contact Information:
        Jones, Marion
        Phone: (303) 398-1265
        Email: jonesm@njhealth.org
MI
  • University of Michigan Health System (Adult), Ann Arbor, MI, 48109
    Contact Information:
        Kruse, Dawn
        Phone: (734) 615-3266
        Email: dmkruse@umich.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
TN
  • Vanderbilt University Medical Center (Adult), Nashville, TN, 37232
    Contact Information:
        Robinette, Michelle
        Phone: (615) 343-9025
        Email: michelle.robinette@vanderbilt.edu
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