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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: |
Recruiting 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. |
| 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. |
| Sponsor Contact Information: |
Leitzinger, Sheila
(206) 256-4904
sheila.leitzinger@gilead.com
|
| 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 |
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Phoenix Children's Hospital (Pediatric), Phoenix, AZ, 85016
Contact Information:
Argel, Natalia
Phone: (602) 546-0343
Email: nargel@phoenixchildrens.com
|
| FL |
-
Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
Contact Information:
DeLuca, Elizabeth
Phone: (904) 697-3804
Email: bdeluca@nemours.org
-
Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
Contact Information:
Kesser, Kenneth (Bert)
Phone: (407) 650-7175
Email: bkesser@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:
Leone Thakkallapalli, Erin
Phone: (617) 355-3197
Email: erin.leone@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
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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
|
| 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
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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
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Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
Contact Information:
Duan, Lorrie
Phone: (513) 636-7089
Email: lorrie.duan@cchmc.org
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Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
Contact Information:
Johnson, Mary Terri
Phone: (614) 722-4766
Email: Terri.Johnson@nationwidechildrens.org
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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
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St. Christopher's Hospital for Children (Pediatric), Philadelphia, PA, 19134
Contact Information:
Aramburo, Marcella
Phone: (215) 427-3816
Email: Marcella.aramburo@drexelmed.edu
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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:
Kennedy, Emma
Phone: (414) 266-4707
Email: ekennedy@mcw.edu
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