Trials Sponsors Conditions Drugs Pricing

Conditions

Cystic Fibrosis

Keywords

Pseudomonas aeruginosaEPIC

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

Study Arms (1)

Observational

Pa negative or concurrently enrolled in the EPIC Clinical Trial

Eligibility Criteria

AgeUp to 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

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.

Sponsors & Collaborators

CF Therapeutics Development Network Coordinating Center
Research networklead
Cystic Fibrosis Foundation
Othercollaborator

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

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: 22554417DERIVED
Rosenfeld 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: 20597081DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

Cystic FibrosisPseudomonas Infections

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

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
PRINCIPAL INVESTIGATOR

Enrollment

1,248 participants (actual enrollment reported by the registry).

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 2004

Date type not reported

This date has not been verified as actual or estimated.

The EPIC Observational Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

Observational

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (54)

Related Publications (3)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

Observational

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (54)

Related Publications (3)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations