The EPIC Observational Study

The EPIC Observational Study: Long-Term Study of Risk Factors and Impact of Pseudomonas aeruginosa and Early Anti-Pseudomonal Treatment in Children with Cystic Fibrosis

Protocol Description

This observational study aims to learn about the conditions or factors that may lead to Pseudomonas aeruginosa (Pa) infections in children with cystic fibrosis (CF). The information collected will aid in understanding what happens to children with CF with regard to their treatment and health after Pa infection occurs. Children whose cultures become positive for Pa while in the observational study may have the option of taking part in a separate treatment study known as the Early Pseudomonas Infection Control (EPIC) Clinical Trial, while participation in the observational study continues. About 1,700 children with CF will take part in this study in approximately 60 CF clinics across the country. Sixty of them will be from Children’s Hospital of Pittsburgh of UPMC.

Eligibility Criteria

Boys and girls with CF up to 12 years of age.
Boys: Up to 12 years
Girls: Up to 12 years

Requirements

Participation in the study will include recording information from clinic visits, collection of a throat culture, and a yearly blood draw.
Visits: 4 per year
Duration: 2.5 to 5 years

Status: Open for Enrollment

Source(s) of Support

Cystic Fibrosis Foundation Therapeutics, Inc

Primary Investigator

David M. Orenstein, MD

Contact Information

For information, please contact:
Elizabeth Hartigan, MPH, RH, CCRC
1-877-296-9026