The EPIC Observational Study
EPIC OBS
Longitudinal Assessment of Risk Factors For and Impact of Pseudomonas Aeruginosa Acquisition and Early Anti-Pseudomonal Treatment in Children With CF
1 other identifier
observational
1,248
1 country
54
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2004
Longer than P75 for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 8, 2008
CompletedFirst Posted
Study publicly available on registry
May 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 1, 2019
January 1, 2019
14.2 years
May 8, 2008
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa.
over the two-to-five-year observational period
To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa.
over the two-to-five-year observational period
Secondary Outcomes (7)
Among subjects who acquire Pa but do not enroll in the EPIC Clinical Trial, to examine the effect of the duration of Pa positive respiratory cultures prior to initiation of anti-pseudomonal therapy and the type and length of anti-pseudomonal therapy.
over the two-to-five year observational period
To describe temporal changes in anti-pseudomonal serology and airway microbiology.
over the two-to-five year observational period
To better define clinical outcomes associated with isolation of S. aureus from respiratory cultures, as well as outcomes associated with emergence of methicillin-resistant S. aureus (MRSA).
over the two-to-five year observational period
To bank Pa and S. aureus isolates and serum samples for future studies to enhance the understanding of early CF lung disease.
over the two-to-five year observational period
To use and bank DNA samples for analyses of genetic factors that may be associated with CF pathogenesis, disease progression, and clinical outcomes.
over the two-to-five year observational period
- +2 more secondary outcomes
Study Arms (1)
Observational
Pa negative or concurrently enrolled in the EPIC Clinical Trial
Eligibility Criteria
Children with Cystic Fibrosis who are Pa negative or concurrently enrolled in the EPIC Clinical Trial
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Children's Hospital of Los Angeles / USC Medical School
Los Angeles, California, 90027, United States
Kaiser Permanente Medical Center
Oakland, California, 94611, United States
Packard Children's Hosp., Stanford University
Palo Alto, California, 94304, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Children's Hospital Denver
Denver, Colorado, 80218, United States
duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
All Children's Hospital CF Center
St. Petersburg, Florida, 33701, United States
Emory University, Cystic Fibrosis Center
Atlanta, Georgia, 30322, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Riley Hospital, Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Maine Medical Center
Portland, Maine, 04102, United States
Children's Hospital, Boston
Boston, Massachusetts, 02115, United States
University of Mass Memorial Health Care
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Spectrum Health Hospitals - DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Children's Hospitals & Clinics
Minneapolis, Minnesota, 55404, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Cardinal Glennon Children's Hospital - St. Louis University
St Louis, Missouri, 63104, United States
Washington University School of Medicine/St. Louis Children's Hospital
St Louis, Missouri, 63310, United States
University of Nebraska
Omaha, Nebraska, 68178, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Albany Medical College
Albany, New York, 12208, United States
Women & Children's Hospital of Buffalo
Buffalo, New York, 14222, United States
Schneider Children's Hospital
New Hyde Park, New York, 11040, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
New York Medical College/Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Rainbow Babies & Childrens Hospital
Cleveland, Ohio, 44106, United States
Children's Hospital
Columbus, Ohio, 43205, United States
Children's Medical Center
Dayton, Ohio, 45404, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02905, United States
LeBonheur Children's Medical Center
Memphis, Tennessee, 38103, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Vermont Children's Hospital at Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Children's Hospital & Regional Medical Center
Seattle, Washington, 98105, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (3)
Rosenfeld M, Emerson J, McNamara S, Thompson V, Ramsey BW, Morgan W, Gibson RL; EPIC Study Group. Risk factors for age at initial Pseudomonas acquisition in the cystic fibrosis epic observational cohort. J Cyst Fibros. 2012 Sep;11(5):446-53. doi: 10.1016/j.jcf.2012.04.003. Epub 2012 May 1.
PMID: 22554417DERIVEDRosenfeld M, Emerson J, McNamara S, Joubran K, Retsch-Bogart G, Graff GR, Gutierrez HH, Kanga JF, Lahiri T, Noyes B, Ramsey B, Ren CL, Schechter M, Morgan W, Gibson RL; EPIC Study Group Participating Clinical Sites. Baseline characteristics and factors associated with nutritional and pulmonary status at enrollment in the cystic fibrosis EPIC observational cohort. Pediatr Pulmonol. 2010 Sep;45(9):934-44. doi: 10.1002/ppul.21279.
PMID: 20597081DERIVEDTreggiari MM, Rosenfeld M, Mayer-Hamblett N, Retsch-Bogart G, Gibson RL, Williams J, Emerson J, Kronmal RA, Ramsey BW; EPIC Study Group. Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study'. Contemp Clin Trials. 2009 May;30(3):256-68. doi: 10.1016/j.cct.2009.01.003. Epub 2009 Jan 15.
PMID: 19470318DERIVED
Biospecimen
For study purposes, OP swabs or expectorated sputum for bacterial culture will be obtained annually beginning in the calendar year of first isolation of Pa from a respiratory culture at the local site laboratory. A serum sample for serology assessment and banking will be obtained annually in conjunction with a scheduled clinical blood draw whenever possible. Under a separate consent, additional blood (6 ml) will be collected for DNA use and banking for studies of genetic factors that may be associated with CF pathogenesis, disease progression, and clinical outcomes. These studies will test for association between gene variants and various CF-related phenotypes using either a targeted (i.e., candidate gene) approach or by performing a whole-genome scan.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret Rosenfeld, MD, MPH
Seattle Children's Hospital
- PRINCIPAL INVESTIGATOR
Ronald L. Gibson, MD, PhD
Seattle Children's Hospital
- PRINCIPAL INVESTIGATOR
Wayne J. Morgan, MD
University of Arizona Health Sciences Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2008
First Posted
May 12, 2008
Study Start
October 1, 2004
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
February 1, 2019
Record last verified: 2019-01