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
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.
National Jewish Health (Adult), Denver, CO, 80206
Contact Information:
Jones, Marion Phone: (303) 398-1265 Email: jonesm@njhealth.org
IN
Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
Contact Information:
Richardson, Stacey Phone: (317) 948-7121 Email: stlyrich@iupui.edu
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
