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Nanci Yuan, MD

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EPIC Observational Study

Contact Information

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

Primary Contact:

Colleen Dunn (650) 736-0388
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

First, it will be closely linked to a multicenter, randomized trial of antimicrobial therapy for new onset Pa airway infection in young patients with Cystic Fibrosis (CF) (Protocol # EPIC-001). Data collected in this study (EPIC-002) will enhance and strengthen the EPIC Clinical Trial, by providing prospectively collected data on pre-clinical trial characteristics potentially affecting response to trial regimens (e.g. anatecendent respiratory symptoms, Pseudomonas Aeruginosa (Pa) mucoidy, Pa serology, and peripheral white blood cell count) and it will provide long-term follow-up data related to trial endpoints after participation in the 18 month clinical trial has ended. These characteristics may potentially affect response to trial regimens. This study will provide follow-up data related to trial endpoints after participation in the 18 month clinical trial has ended. In addition, the EPIC Observational Study will provide a cohort of children who acquire Pa but do not enroll in the concurrent EPIC Clinical Trial. This will allow investigation of the characteristics of these non-enrolled participants, the period prevalence of antibiotic use in this population, and the outcomes associated with non protocol-based #usual care.# Second, this study will also serve as an epidemiologic study of the risk factors for and clinical impact of initial Pa acquisition and anti-pseudomonal therapy. It will provide for more generalizable results and more precise risk estimates for previously identified risk factors for Pa acquisition and it will allow for exploration of novel risk factors. Better understanding of the clinical outcomes associated with Pa acquisition and the outcomes associated with different types of anti-pseudomonal therapies will inform the development of rational early intervention treatment regimens. Better knowledge about temporal relationships between respiratory signs and symptoms, Pa serology, and CF airway microbiology may lead to improved strategies for early detection of Pa and could have important implications for the timing of interventions aimed at preventing or treating early Pa acquisition. Third, this study will serve as an important source of Pa isolates and serum samples that will be banked for future studies designed to enhance the understanding of early CF lung disease, e.g., microarray investigations of early Pa isolates, or investigations to identify proteomic biomarkers of airway inflammation.

Recruiting Status:

No longer recruiting

Stanford Recruiting Status:

Completed

Condition(s):

Intervention(s):

  • Behavior: n/a

Phase:

N/A

Eligibility

Ages Eligible for Study:

Any Age to 12 years

Genders Eligible for Study:

Female

Health of Volunteers:

People with the conditions listed in this trial can participate as controls.

Key Inclusion Criteria:

1. Male or female ages less than or equal to 12 years.
2. Diagnosis of Cystic Fibrosis (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.
3. No prior isolation of Pa from respiratory cultures, or, if prior isolation of Pa from respiratory cultures, at
least a two-year history of Pa negative cultures (greater than or equal to 1 culture/ year), or concurrently
enrolled in the EPIC Clinical Trial.

Key Exclusion Criteria:

Inability to meet the inclusion criteria.

Additional Study Details

Official Title:

The EPIC Observational Study: Longitudinal Assessment of Risk Factors For and Impact of Pseudomonas Aeroginosa Acquisition and Early Anti-Pseudomonal Treatment in Children with CF (EPIC-002)

Anticipated start date:

1/1/2008

Lead Sponsor:

Cystic Fibrosis Foundation

Investigator(s):

Study Type:

Observational

Purpose:

NOTNEEDED

Duration:

Longitudinal

Selection:

Defined Population

Timing:

Prospective

Total Number to be Enrolled:

1400

Total Number to be Enrolled at Stanford:

25

More Information

Trial Unique Id: SU-02082008-1008

Locations & Contacts

Stanford Locations & Contacts:

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

Primary Contact:

Colleen Dunn (650) 736-0388

Non-Stanford Locations:

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated:

4/1/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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