The EPIC Observational Study

Completed

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00676169

Run by

CF Therapeutics Development Network Coordinating Center

People needed

1248

Starts

2004-10-01

Expected to finish

2018-12-01

Last updated by the study team

2019-02-01

Who can join

Age: any, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ages less than or equal to 12 years.
• Diagnosis of CF based upon the criteria established by the 1997 CF Consensus Conference: (i) sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis; or (ii) genotype with two identifiable mutations consistent with CF; or (iii) an abnormal nasal transepithelial potential difference, and (iv) one or more clinical features consistent with CF.
• No prior isolation of Pa from respiratory cultures (1 or more cultures in 24 months prior to enrollment), or, if prior isolation of Pa from respiratory cultures, at least a two-year history of Pa negative cultures (1 or more cultures/year), or concurrently enrolled in the EPIC Clinical Trial.
• Signed informed consent to participate in data submission to the CFF National Patient Registry.
• Signed informed consent by parent or legal guardian.

Where it is running

• Children's Hospital of Los Angeles / USC Medical School — Los Angeles, California, United States
• Kaiser Permanente Medical Center — Oakland, California, United States
• Packard Children's Hosp., Stanford University — Palo Alto, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's Hospital Denver — Denver, Colorado, United States
• duPont Hospital for Children — Wilmington, Delaware, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• All Children's Hospital CF Center — St. Petersburg, Florida, United States
• Emory University, Cystic Fibrosis Center — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Riley Hospital, Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Maine Medical Center — Portland, Maine, United States
• Children's Hospital, Boston — Boston, Massachusetts, United States
• University of Mass Memorial Health Care — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Spectrum Health Hospitals - DeVos Children's Hospital — Grand Rapids, Michigan, United States
• Children's Hospitals & Clinics — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Cardinal Glennon Children's Hospital - St. Louis University — St Louis, Missouri, United States
• The University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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