The EPIC Observational Study: Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa (Pa) Airway Infection in Young Patients with Cystic Fibrosis

HUMAN CLINICAL - CONFIDENTIAL The purpose of this study is to better define risk factors preceding first isolation of Pseudomonas aeruginosa (Pa) from respiratory cultures in cystic fibrosis (CF) lung disease and to better define clinical outcomes associated with acquisition of Pa. This study will also collect and bank DNA samples for current and future studies designed to enhance the understanding of the pathogenesis of CF Study Site will perform the research and administrative work ("Work") as specified herein, including, without limitation, providing all reasonably necessary facilities, equipment and materials; performing all reasonably necessary activities; keeping appropriate records; and reporting the results pursuant to the conduct of a scientific investigation involving human subjects ("Patients") in accordance with the applicable Protocol and other specific instructions. The Work to be conducted by Study Site under this Agreement shall be in accordance with (i) the clinical trial Protocol, as may be amended from time to time in writing, and (ii) specific instructions regarding patient safety or technical and scientific aspects of the Study as may be transmitted to the Study Site by or on the behalf of Seattle Children'sStudy Site will perform the research and administrative work ("Work") as specified herein, including, without limitation, providing all reasonably necessary facilities, equipment and materials; performing all reasonably necessary activities; keeping appropriate records; and reporting the results pursuant to the conduct of a scientific investigation involving human subjects ("Patients") in accordance with the applicable Protocol and other specific instructions. The Work to be conducted by Study Site under this Agreement shall be in accordance with (i) the clinical trial Protocol, as may be amended from time to time in writing, and (ii) specific instructions regarding patient safety or technical and scientific aspects of the Study as may be transmitted to the Study Site by or on the behalf of Seattle Children's