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Study Name: Aztreonam (AZLI) in Infants and Children with CF and New Onset Pseudomonas Aeruginosa
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Gilead
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): Cayston
Number of Participants Being Recruited: 80
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this trial is to see how many infants and children with CF treated with Aztreonam Inhalation Solution (AZLI) for 28 days will have negative respiratory cultures for Pseudomonas Aeruginosa in follow-up study visits. All study participants will have a newly detected Pseudomonas Aeruginosa lung infection based upon respiratory culture results. They will begin a 28-day course of AZLI taken 3 times a day. After completing this 28-day course of treatment, study participants will have repeat respiratory cultures taken at follow-up visits over a 6-month monitoring period.
ELIGIBILITY
Age: 3 Months - 17 Years
FEV1: >= 90 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Documented new onset of positive lower respiratory tract culture for PA within 30 days prior to study entry
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: Leitzinger, Sheila
(206) 256-4904
sheila.leitzinger@gilead.com
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01375049?term=gilead+and+cystic+fibrosis&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.
AZ
  • Phoenix Children's Hospital (Pediatric), Phoenix, AZ, 85016
    Contact Information:
        Argel, Natalia
        Phone: (602) 933-0343
        Email: Nargel@phoenixchildrens.com
FL
  • Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
    Contact Information:
        DeLuca, Elizabeth
        Phone: (904) 697-3804
        Email: Elizabeth.DeLuca@nemours.org
  • Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
    Contact Information:
        Price, Angela
        Phone: (407) 650-7634
        Email: alprice@nemours.org
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
MA
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Fowler, Robert
        Phone: (617) 355-1834
        Email: Robert.fowler@childrens.harvard.edu
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
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
NY
  • 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
  • SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
    Contact Information:
        Lindner, Donna
        Phone: (315) 464-7525
        Email: lindnerd@upstate.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
  • Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
    Contact Information:
        Duan, Lorrie
        Phone: (513) 636-7089
        Email: lorrie.duan@cchmc.org
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
  • Toldeo Children's Hospital (Pediatric), Toledo, OH, 43606
    Contact Information:
        Houser, Kelly
        Phone: (419) 291-4630
        Email: kelly.houser@promedica.org
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
  • 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
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
WI
  • 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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