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Study Name: Longitudinal Assessment of Risk Factors for and Impact of Pseudomonas aeruginosa and Early Anti-Pseudomonal Treatment in Children with CF
Study Type: Observational
Intervention Category: Not Applicable
Study Sponsor: Rosenfeld, Margaret

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: Other
Recruitment Status: Trial Completed
Study Drug(s): Not Applicable
Number of Participants Being Recruited: 1700
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This observational study is being conducted to learn what may lead to lung infections caused by Pseudomonas aeruginosa (Pa) in children with CF and what the impact of those infections may be. The original five year study has been extended to allow information to be collected about lung infections, symptoms, and bacteria for up to 10 years in children who enroll in the study. Participants who participated in this study and had Pa isolated during the study and fulfilled eligibility criteria were had the option to enroll in the EPIC clinical trial.
ELIGIBILITY
Age: 1 Days - 12 Years
FEV1: Not Applicable
P. aeruginosa status: Negative
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Subjects eligible for this trial will have had no prior isolation of Pa from respiratory cultures (documented as negative in at least 1 culture 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. In addition, patients enrolled in the EPIC Clinical trial will automatically be enrolled in the EPIC Observational trial after completion of EPIC Clinical.
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Rosenfeld, Margaret
(206) 987-2024 X4
margaret.rosenfeld@seattlechildrens.org
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00676169?term=EPIC+and+cystic+fibrosis&rank=3
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

The study cohort for this publication included 889 children with CF =12 years of age from the EPIC Observational Study who had no isolation of Pa from respiratory cultures. The primary endpoint for the analysis was age at initial Pa acquisition, defined as the age at first isolation of Pa from a clinically-collected respiratory culture.
CFTR mutations with minimal function were associated with earlier Pa acquisition compared to mutations with residual function; the median age at Pa acquisition was 2.9 years among participants with minimal CFTR function vs.10.3 years for those with residual CFTR function (hazard ratio (HR) comparing minimal to residual CFTR function 2.87 (95% CI 1.88, 4.39)). Home environmental exposure as possible risk factors was evaluated. None of these factors, including cigarette smoke, hot tub use, breastfeeding, or daycare attendance, was associated with age at initial Pa acquisition. Newborn screening was not associated with age at Pa acquisition. Key associations were validated in a CF Foundation National Patient Registry replication cohort.

Secondary Efficacy:

Not Applicable

Safety:

Not applicable

Citation:

Pediatr Pulmonol 2010;45(9):934-44

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