The EPIC Observational Study

Not Recruiting

Trial ID: NCT00676169


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.

Official Title

Longitudinal Assessment of Risk Factors For and Impact of Pseudomonas Aeruginosa Acquisition and Early Anti-Pseudomonal Treatment in Children With CF

Stanford Investigator(s)


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

   - Signed informed consent by parent or legal guardian.

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Colleen Dunn