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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: Trial 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.
AL
  • 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
CA
  • 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
CO
  • Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
    Contact Information:
        Pardee, Churee
        Phone: (720) 777-6162
        Email: churee.pardee@childrenscolorado.org
DE
  • Alfred I. duPont Hospital for Children (Pediatric and Adult), Wilmington, DE, 19899
    Contact Information:
        Budd, Sandra
        Phone: (302) 651-6536
        Email: sbudd@nemours.org
FL
  • Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
    Contact Information:
        DeLuca, Elizabeth
        Phone: (904) 697-3804
        Email: Elizabeth.DeLuca@nemours.org
  • All Children's Hospital (Pediatric), St. Petersburg, FL, 33701
    Contact Information:
        Hosler, Kathy
        Phone: (727) 767-7247
        Email: kathy.hosler@jhmi.edu
GA
  • Emory University (Pediatric), Atlanta, GA, 30322
    Contact Information:
        Hunter, Eric
        Phone: (404) 785-3102
        Email: eahunte@emory.edu
  • Georgia Regents University (Pediatric), Augusta, GA, 30912
    Contact Information:
        Stapp, Heidi
        Phone: (706) 721-7699
        Email: hstapp@gru.edu
IA
  • University of Iowa (Pediatric), Iowa City, IA, 52242
    Contact Information:
        Teresi, Mary
        Phone: (319) 384-7546
        Email: mary-teresi@uiowa.edu
IL
  • 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
IN
  • Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
    Contact Information:
        Bendy, Lisa
        Phone: (317) 948-7152
        Email: lbendy@iupui.edu
KY
  • University of Kentucky (Pediatric), Lexington, KY, 40536
    Contact Information:
        Watts, Tammy
        Phone: (859) 257-5087
        Email: Tammy.watts@uky.edu
MA
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Fowler, Robert
        Phone: (617) 355-1834
        Email: Robert.fowler@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
ME
  • Maine Medical Partners Pediatric Specialty Care (Pediatric), Portland, ME, 04102
    Contact Information:
        Milliard, Carrie
        Phone: (207) 662-6712
        Email: millic@mmc.org
MI
  • 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:
        Gile, Cynthia
        Phone: (616) 391-6148
        Email: Cynthia.Gile@spectrumhealth.org
MN
  • Children's Hospitals and Clinics (Pediatric), Minneapolis, MN, 55404
    Contact Information:
        Johnson, Mahrya
        Phone: (612) 813-6384
        Email: mahrya.johnson@childrensmn.org
MO
  • 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:
        Cooper, Amy
        Phone: (314) 678-5457
        Email: acoope16@slu.edu
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Hicks, Tina
        Phone: (314) 747-2707
        Email: Hicks_T@kids.wustl.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
MS
  • University of Mississippi Medical Center (Pediatric), Jackson, MS, 39216
    Contact Information:
        Adcock, Kim
        Phone: (601) 815-9172
        Email: kadcock@umc.edu
NC
  • 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
NE
  • University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
    Contact Information:
        Telfer, Raquel
        Phone: (402) 559-6275
        Email: raquel.telfer@unmc.edu
  • University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
    Contact Information:
        Acquazzino, Diane
        Phone: (402) 559-6275
        Email: dracquaz@unmc.edu
NH
  • Dartmouth Hitchcock Medical Center (Adult), Lebanon, NH, 03756
    Contact Information:
        Dorman, Dana
        Phone: (603) 629-8311
        Email: Dana.B.Dorman@hitchcock.org
NJ
  • Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
    Contact Information:
        Marra, Bridget
        Phone: (732) 222-4474
        Email: bmarra@barnabashealth.org
NY
  • Albany Medical College (Pediatric), Albany, NY, 12208
    Contact Information:
        Evans, Terese
        Phone: (518) 262-5293
        Email: evansmt@mail.amc.edu
  • Women and 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:
        Nix, Nancy
        Phone: (585) 275-8580
        Email: Nancy_Nix@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) 594-2348
        Email: ingrid_gherson@nymc.edu
OH
  • 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:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
  • Dayton Children's Hospital (Pediatric), Dayton, OH, 45404
    Contact Information:
        Bartosik, Sandy
        Phone: (937) 641-4004
        Email: bartosiks@childrensdayton.org
OR
  • Oregon Health Sciences University (Pediatric), Portland, OR, 97201
    Contact Information:
        Simmons, Kim
        Phone: (503) 494-7807
        Email: simmonsk@ohsu.edu
PA
  • 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:
        Fritsch, Jacqueline
        Phone: (215) 427-3816
        Email: jacqueline.fritsch@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
TN
  • 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
TX
  • 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
UT
  • Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
    Contact Information:
        Vroom, Jane
        Phone: (801) 587-7458
        Email: jane.vroom@hsc.utah.edu
VA
  • University of Virginia (Pediatric), Charlottesville, VA, 22908
    Contact Information:
        Moss, Patricia
        Phone: (434) 243-2876
        Email: pcm2v@virginia.edu
VT
  • Vermont Children's Hospital (Pediatric), Burlington, VT, 05401
    Contact Information:
        Burns, Stephanie
        Phone: (802) 847-2103
        Email: Stephanie.Burns@vtmednet.org
WA
  • Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
    Contact Information:
        McNamara, Sharon
        Phone: (206) 987-3921 X1
        Email: sharon.mcnamara@seattlechildrens.org
WI
  • 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:
        Kump, Theresa
        Phone: (414) 337-7144
        Email: tkump@mcw.edu
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