|
|
| Study Name: |
Expanded Access Program for Aztreonam Lysine for Inhalation |
| Study Type: |
Interventional |
| Intervention Category: |
Anti-Infective |
| Study Sponsor: |
Gilead |
| Study Phase: |
Other |
| Recruitment Status: |
Trial Completed |
| Study Drug(s): |
Cayston |
| Number of Participants Being Recruited: |
300 |
| Single / Multi-Center: |
Multi-Center |
| STUDY BACKGROUND INFORMATION: |
| Aztreonam Lysine for Inhalation is now available to people with CF who meet specific criteria through an expanded access program. Although not yet approved by the FDA for general use, Aztreonam Lysine for Inhalation will be available to patients with chronic Pseudomonas aeruginosa airway infection who have limited treatment options and are at risk for disease progression. |
| Age: |
>= 6 Years
|
| FEV1: |
1 - 50 Percent Predicted
|
| P. aeruginosa status: |
Positive |
| B. cepacia status: |
Negative |
Other Primary Eligibility Requirements:
|
| 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: |
Call Center at Parexel, Gilead EAP
(800) 490-2697
GileadEAP@parexel.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. |
| AK |
-
Providence Alaska Medical Center (Pediatric and Adult), Anchorage, AK, 99508
Contact Information:
Roberts, Vicki
Phone: (907) 212-3299
Email: vicki.roberts@providence.org
|
| AZ |
-
Phoenix Children's Hospital (Pediatric), Phoenix, AZ, 85016
Contact Information:
Argel, Natalia
Phone: (602) 546-0343
Email: nargel@phoenixchildrens.com
|
| CA |
-
Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
Contact Information:
Ortega, Ricardo
Phone: (323) 361-6639
Email: rortega@chla.usc.edu
|
| CO |
-
Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
Contact Information:
Pardee, Churee
Phone: (720) 777-6162
Email: chureeporn.pardee@childrenscolorado.org
-
National Jewish Health (Adult), Denver, CO, 80206
Contact Information:
Jones, Marion
Phone: (303) 398-1265
Email: jonesm@njhealth.org
|
| CT |
-
Central Connecticut Cystic Fibrosis Center (Pediatric), Hartford, CT, 06102
Contact Information:
Drapeau, Ginny
Phone: (860) 545-9434
Email: gdrapea@ccmckids.org
-
Central Connecticut Cystic Fibrosis Center (Adult), Hartford, CT, 06107
Contact Information:
Trifiro, Sandra
Phone: (860) 545-3416
Email: strifiro@harthosp.org
|
| FL |
-
University of Florida (Adult), Gainesville, FL, 32610
Contact Information:
Nichols, Wanda
Phone: (352) 273-8732
Email: nichowj@medicine.ufl.edu
-
Central Florida Pulmonary Group (Adult), Orlando, FL, 32803
Contact Information:
Chemtob, Candace
Phone: (407) 383-4308
Email: chemtob@earthlink.net
-
All Children's Hospital (Pediatric), St. Petersburg, FL, 33701
Contact Information:
Hosler, Kathy
Phone: (727) 767-7247
Email: Kathy.Hosler@allkids.org
-
Tampa General Hospital (Adult), Tampa, FL, 33606
Contact Information:
Roberson, Suzanne
Phone: (813) 844-7179
Email: sroberson@tgh.org
|
| ID |
-
Saint Luke's Cystic Fibrosis Center of Idaho (Pediatric and Adult), Boise, ID, 83712
Contact Information:
Durham, Dixie
Phone: (208) 381-7334
Email: durhamd@slhs.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
-
University of Chicago (Pediatric), Chicago, IL, 60637
Contact Information:
Cheatham, Jeannine
Phone: (773) 834-0192
Email: jcheatham@peds.bsd.uchicago.edu
|
| KS |
-
Via Christi - Saint Francis Campus (Pediatric), Wichita, KS, 67218
Contact Information:
Miller, Sheri
Phone: (316) 268-6028
Email: Sheri.Miller@viachristi.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
|
| MI |
-
Wayne State University Harper University Hospital (Adult), Detroit, MI, 48201
Contact Information:
Cahill, James
Phone: (313) 745-2221
Email: jcahil@med.wayne.edu
|
| MN |
-
Children's Hospitals and Clinics (Pediatric), Minneapolis, MN, 55404
Contact Information:
Johnson, Mahrya
Phone: (612) 813-6384
Email: mahrya.johnson@childrensmn.org
-
The Minnesota Cystic Fibrosis Center (Pediatric), Minneapolis, MN, 55455
Contact Information:
Grover, Patricia
Phone: (612) 626-7425
Email: Grove026@umn.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
|
| NJ |
-
Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
Contact Information:
Marra, Bridget
Phone: (732) 222-4474
Email: bmarra@sbhcs.com
-
Bristol-Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital (Pediatric), New Brunswick, NJ, 09801
Contact Information:
Cerracchio, Lisa
Phone: (732) 235-6050
Email: cerracli@umdnj.edu
|
| NM |
-
University of New Mexico School of Medicine (Adult), Albuquerque, NM, 87131
Contact Information:
Redway, Abby
Phone: (505) 272-5886
Email: ajredway@salud.unm.edu
|
| NY |
-
Children's Hospital of Buffalo (Pediatric), Buffalo, NY, 14222
Contact Information:
Caci, Nadine
Phone: (716) 878-7524
Email: ncaci@upa.chob.edu
-
Long Island Jewish Medical Center Adult Program (Adult), New Hyde Park, NY, 11040
Contact Information:
Wann, Li-Chen
Phone: (516) 712-9608
Email: LCWann@nshs.edu
-
Beth Israel Medical Center (Pediatric), New York, NY, 10003
Contact Information:
Grece, Carroll Anne
Phone: (212) 420-4196
Email: cgrece@chpnet.org
-
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
|
| 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:
Johnson, Mary Terri
Phone: (614) 722-4766
Email: Terri.Johnson@nationwidechildrens.org
-
Toldeo Children's Hospital (Pediatric), Toledo, OH, 43606
Contact Information:
Houser, Kelly
Phone: (419) 291-4630
Email: kelly.houser@promedica.org
|
| OK |
-
Oklahoma Cystic Fibrosis Center (Pediatric), Oklahoma City, OK, 73104
Contact Information:
Fox, Jodie
Phone: (405) 271-6216
Email: Jodie-Fox@ouhsc.edu
|
| PA |
-
Children's Hospital of Philadelphia University of Pennsylvania (Pediatric), Philadelphia, PA, 19104
Contact Information:
Kubrak, Christina
Phone: (267) 426-5135
Email: kubrak@email.chop.edu
-
Drexel University College of Medicine (Adult), Philadelphia, PA, 19129
Contact Information:
Hillman, Judy
Phone: (215) 762-5462
Email: jhillman@drexelmed.edu
|
| SD |
-
Sanford Medical Center (Pediatric), Sioux Falls, SD, 57117
Contact Information:
Hanson, Dawn
Phone: (605) 312-1033
Email: Dawn.Hanson@sanfordhealth.org
|
| TX |
-
Cook Children's Medical Center (Pediatric), Fort Worth, TX, 76104
Contact Information:
Morris, Trudy
Phone: (682) 885-1244
Email: Trudy.Morris@cookchildrens.org
-
Christus Santa Rose Children's Hospital (Adult), San Antonio, TX, 78212
Contact Information:
Phillips, Teresa
Phone: (210) 223-3010
Email: tphillips@acra-sa.com
|
| UT |
-
Intermountain Cystic Fibrosis Center (Adult), Salt Lake City, UT, 84132
Contact Information:
Packer, Kristyn
Phone: (801) 585-0401
Email: kristyn.packer@hsc.utah.edu
|
| VA |
-
Children's Hospital of the King's Daughters (Pediatric), Norfolk, VA, 23507
Contact Information:
Perkins, Susan
Phone: (757) 668-6416
Email: PerkinSR@evms.edu
-
Virginia Commonwealth University (Pediatric), Richmond, VA, 23235
Contact Information:
Ward, Matthew
Phone: (804) 628-3093
Email: wardmt@vcu.edu
|
| WA |
-
University of Washington Medical Center (Adult), Seattle, WA, 98195
Contact Information:
Wolfstone, Alycia
Phone: (206) 685-3995
Email: aewolf@u.washington.edu
|
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