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Study Name: Five Year Extension Study to Evaluate Risk Factors for and Inpact of P. aeruginosa Acquisition
Study Type: Observational
Intervention Category: Not Applicable
Study Sponsor: Rosenfeld, Margaret

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): Not Applicable
Number of Participants Being Recruited: 1780
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This observational study is being conducted to learn what may lead to lung infections caused by Pseudomonas aeruginosa (Pa) in children with CF and what the impact of those infections may be. The original five year study has been extended to allow information to be collected about lung infections, symptoms, and bacteria for up to 10 years in children who enroll in the study. Participants who participated in this study and had Pa isolated during the study and fulfilled eligibility criteria were had the option to enroll in the EPIC clinical trial.
ELIGIBILITY
Age: 1 Days - 12 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

This study is an extension of the EPIC Observational study.
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: Antoine, Liebe
(206) 884-7510
liebe.antoine@seattlechildrens.org
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00676169?term=EPIC+observation&rank=2
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Secondary Efficacy:

Safety:

Citation:

J Cyst Fibros 2014;13(5):542-9

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