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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
TRIAL RESULTS:
Primary Efficacy:

Secondary Efficacy:

Safety:

Citation:

Ann Amer Thorac Soc 2015;In Press

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