Status:
COMPLETED
The EPIC Observational Study
Lead Sponsor:
CF Therapeutics Development Network Coordinating Center
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
Up to 12 years
Brief Summary
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 ...
Detailed Description
The EPIC Observational Study is a longitudinal, prospective, observational study that was originally conducted at 59 sites. The current five-year extension study is being conducted at 54 sites. The E...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
1248 Patients enrolled
Trial Details
Trial ID
NCT00676169
Start Date
October 1 2004
End Date
December 1 2018
Last Update
February 1 2019
Active Locations (54)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Children's Hospital of Los Angeles / USC Medical School
Los Angeles, California, United States, 90027
3
Kaiser Permanente Medical Center
Oakland, California, United States, 94611
4
Packard Children's Hosp., Stanford University
Palo Alto, California, United States, 94304