CFF - Five Year Extension Study to Evaluate Risk Factors for and Inpact of P. aeruginosa Acquisition

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Clinical Research Information Sheet

Study Name:

Five Year Extension Study to Evaluate Risk Factors for and Inpact of P. aeruginosa Acquisition

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:

Recruiting Completed

Study Drug(s):

Not Applicable

Number of Participants Being Recruited:

1780

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:	Not applicable
B. cepacia status:	Not applicable
Other Primary Eligibility Requirements: This study is an extension of the EPIC Observational study.
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:

Antoine, Liebe
(206) 884-7510
liebe.antoine@seattlechildrens.org

Trial Specific Link on ClinicalTrials.gov:

http://www.clinicaltrials.gov/ct2/show/NCT00676169?term=EPIC+observation&rank=2

Clinical Research Terms Glossary:

Click here

PARTICIPATING SITES:

The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.

The Children's Hospital/University of Alabama at Birmingham (Pediatric), Birmingham, AL, 35233
Contact Information:
    Hathorne, Heather
    Phone: (205) 638-9568
    Email: hhathorne@peds.uab.edu

Kaiser Permanente Medical Care Program (Pediatric), Oakland, CA, 94611
Contact Information:
    Lee, Julie
    Phone: (510) 752-7558
    Email: julie.lee@kp.org
Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
Contact Information:
    Dunn, Colleen
    Phone: (650) 736-0388
    Email: cedunn@stanford.edu
The Regents of the University of California, San Francisco (Pediatric), San Francisco, CA, 94143
Contact Information:
    Moreno, Courtney
    Phone: (415) 476-2984
    Email: morenoc@peds.ucsf.edu

Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
Contact Information:
    Pardee, Churee
    Phone: (720) 777-6162
    Email: chureeporn.pardee@childrenscolorado.org

Alfred I. duPont Hospital for Children (Pediatric and Adult), Wilmington, DE, 19899
Contact Information:
    Budd, Sandra
    Phone: (302) 651-6536
    Email: sbudd@nemours.org

Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
Contact Information:
    DeLuca, Elizabeth
    Phone: (904) 697-3804
    Email: bdeluca@nemours.org
All Children's Hospital (Pediatric), St. Petersburg, FL, 33701
Contact Information:
    Hosler, Kathy
    Phone: (727) 767-7247
    Email: Kathy.Hosler@allkids.org

Emory University (Pediatric), Atlanta, GA, 30322
Contact Information:
    Hunter, Eric
    Phone: (404) 727-9960
    Email: eahunte@emory.edu
Georgia Health Sciences University (Pediatric), Augusta, GA, 30912
Contact Information:
    Stapp, Heidi
    Phone: (706) 721-7699
    Email: HSTAPP@gru.edu

University of Iowa (Pediatric), Iowa City, IA, 52242
Contact Information:
    Teresi, Mary
    Phone: (319) 384-7546
    Email: mary-teresi@uiowa.edu

Ann and Robert H. Lurie Children's Hospital of Chicago (Pediatric), Chicago, IL, 60611
Contact Information:
    Singh, Noopur
    Phone: (312) 227-6861
    Email: nosingh@luriechildrens.org

Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
Contact Information:
    Richardson, Stacey
    Phone: (317) 948-7121
    Email: stlyrich@iupui.edu

University of Kentucky (Pediatric), Lexington, KY, 40536
Contact Information:
    Watts, Tammy
    Phone: (859) 257-5087
    Email: twatt2@uky.edu

Children's Hospital Boston (Pediatric), Boston, MA, 02115
Contact Information:
    Leone Thakkallapalli, Erin
    Phone: (617) 355-3197
    Email: erin.leone@childrens.harvard.edu
University of Massachusetts Memorial Health Care (Pediatric), Worcester, MA, 01655
Contact Information:
    Longtine, Karen
    Phone: (508) 856-6970
    Email: Karen.Longtine@umassmed.edu

Maine Medical Partners Pediatric Specialty Care (Pediatric), Portland, ME, 04102
Contact Information:
    Milliard, Carrie
    Phone: (207) 662-6712
    Email: millic@mmc.org

University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
Contact Information:
    Kruse, Dawn
    Phone: (734) 615-3266
    Email: dmkruse@umich.edu
Children's Hospital of Michigan (Pediatric), Detroit, MI, 48201
Contact Information:
    Van Wagnen, Catherine
    Phone: (313) 745-4737
    Email: cvanwag@med.wayne.edu
Helen DeVos Women and Children's Center (Pediatric), Grand Rapids, MI, 49503
Contact Information:
    Symington, Thomas
    Phone: (616) 391-9366
    Email: thomas.symington@spectrumhealth.org

Children's Hospitals and Clinics (Pediatric), Minneapolis, MN, 55404
Contact Information:
    Johnson, Mahrya
    Phone: (612) 813-6384
    Email: mahrya.johnson@childrensmn.org

The Children's Mercy Hospital (Pediatric and Adult), Kansas City, MO, 64108
Contact Information:
    Schmoll, Candy
    Phone: (816) 701-1339
    Email: cschmoll@cmh.edu
Cardinal Glennon Children's Medical Center (St. Louis University) (Pediatric), St. Louis, MO, 63104
Contact Information:
    Kociela, Vikki
    Phone: (314) 577-5608
    Email: kocielav@slu.edu
St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
    Rodgers, Denise
    Phone: (314) 286-1176
    Email: rodgers@kids.wustl.edu
St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
    Burks, Patricia
    Phone: (314) 454-5175
    Email: Burks_P@kids.wustl.edu

University of Mississippi Medical Center (Pediatric), Jackson, MS, 39216
Contact Information:
    Adcock, Kim
    Phone: (601) 815-9172
    Email: kadcock@umc.edu

University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
Contact Information:
    Barlow, Carol
    Phone: (919) 966-9146
    Email: cbarlow@med.unc.edu

University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
Contact Information:
    Acquazzino, Diane
    Phone: (402) 559-6275
    Email: dracquaz@unmc.edu
University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
Contact Information:
    Telfer, Raquel
    Phone: (402) 559-6275
    Email: raquel.telfer@unmc.edu

Dartmouth Hitchcock Medical Center (Pediatric), Lebanon, NH, 03756
Contact Information:
    Dorman, Dana
    Phone: (603) 629-8311
    Email: Dana.B.Dorman@hitchcock.org

Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
Contact Information:
    Marra, Bridget
    Phone: (732) 222-4474
    Email: bmarra@sbhcs.com

Albany Medical College (Pediatric), Albany, NY, 12208
Contact Information:
    Evans, Terese
    Phone: (518) 262-5293
    Email: evansmt@mail.amc.edu
Children's Hospital of Buffalo (Pediatric), Buffalo, NY, 14222
Contact Information:
    Caci, Nadine
    Phone: (716) 878-7524
    Email: ncaci@upa.chob.edu
The Steven & Alexandra Cohen Children's Medical Center of New York (Pediatric), Great Neck, NY, 11021
Contact Information:
    Galvin, Susan
    Phone: (516) 622-5281
    Email: sgalvin@nshs.edu
University of Rochester Medical Center Strong Memorial (Pediatric), Rochester, NY, 14642
Contact Information:
    Jenks, Nancy
    Phone: (585) 275-8580
    Email: nancy_jenks@urmc.rochester.edu
SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
Contact Information:
    Lindner, Donna
    Phone: (315) 464-7525
    Email: lindnerd@upstate.edu
New York Medical College/Westchester Medical Center (Pediatric), Valhalla, NY, 10595
Contact Information:
    Gherson, Ingrid
    Phone: (914) 594-3320
    Email: ingrid_gherson@nymc.edu

Children's Hospital Medical Center of Akron (Pediatric), Akron, OH, 44308
Contact Information:
    Ouellette, Deborah
    Phone: (330) 543-3089
    Email: douellette@chmca.org
University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
Contact Information:
    Ksenich, Roberta (Bobbi)
    Phone: (216) 844-5733
    Email: Roberta.Ksenich@UHHospitals.org
Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
Contact Information:
    Johnson, Mary Terri
    Phone: (614) 722-4766
    Email: Terri.Johnson@nationwidechildrens.org
The Children's Medical Center of Dayton (Pediatric), Dayton, OH, 45404
Contact Information:
    Bartosik, Sandy
    Phone: (937) 641-4004
    Email: bartosiks@childrensdayton.org

Oregon Health Sciences University (Pediatric), Portland, OR, 97201
Contact Information:
    Andrews-Chavez, Brian
    Phone: (503) 494-6974
    Email: andrewbr@ohsu.edu

Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
Contact Information:
    Kitch, Diane
    Phone: (717) 531-5646
    Email: dkitch@psu.edu
St. Christopher's Hospital for Children (Pediatric), Philadelphia, PA, 19134
Contact Information:
    Aramburo, Marcella
    Phone: (215) 427-3816
    Email: Marcella.aramburo@drexelmed.edu
Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
Contact Information:
    Hartigan, Elizabeth
    Phone: (412) 692-7060
    Email: elizabeth.hartigan@chp.edu

University of Tennessee CF Care and Research Center (Pediatric), Memphis, TN, 38103
Contact Information:
    Culbreath, Barbara
    Phone: (901) 287-5351
    Email: bculbreath@uthsc.edu
Vanderbilt Children's Hospital Vanderbilt University Medical Center (Pediatric), Nashville, TN, 37232
Contact Information:
    Berry, Pamela
    Phone: (615) 936-8308
    Email: pamela.berry@Vanderbilt.Edu

Cook Children's Medical Center (Pediatric), Fort Worth, TX, 76104
Contact Information:
    Morris, Trudy
    Phone: (682) 885-1244
    Email: Trudy.Morris@cookchildrens.org
Baylor College of Medicine (Pediatric), Houston, TX, 77030
Contact Information:
    Schaap, Nicoline
    Phone: (832) 822-4252
    Email: nxschaap@texaschildrens.org

Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
Contact Information:
    Vroom, Jane
    Phone: (801) 587-7458
    Email: jane.vroom@hsc.utah.edu

University of Virginia (Pediatric), Charlottesville, VA, 22908
Contact Information:
    Moss, Patricia
    Phone: (434) 243-2876
    Email: pcm2v@virginia.edu

Vermont Children's Hospital (Pediatric), Burlington, VT, 05401
Contact Information:
    Diehl, Sandra
    Phone: (802) 847-3884
    Email: Sandra.Diehl@uvm.edu

Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
Contact Information:
    McNamara, Sharon
    Phone: (206) 987-3921 X1
    Email: sharon.mcnamara@seattlechildrens.org

University of Wisconsin (Pediatric), Madison, WI, 53792
Contact Information:
    Makholm, Linda
    Phone: (608) 262-0340
    Email: Lmakholm@uwhealth.org
Children's Hospital of Wisconsin Froedtert & Medical College of Wisconsin (Pediatric), Milwaukee, WI, 53201
Contact Information:
    Kennedy, Emma
    Phone: (414) 266-4707
    Email: ekennedy@mcw.edu