Cystic Fibrosis Foundation - Click here for homepage
Stay Informed  |  Volunteer  |  Clinical Trials

In This Section

Quick Links

Find a Chapter

Print  

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.
ELIGIBILITY
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.
FOR MORE INFORMATION:
Sponsor Contact Information: Call Center at Parexel, Gilead EAP
(800) 490-2697
GileadEAP@parexel.com
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00499720?term=cystic+fibrosis&rank=52
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.
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) 933-0343
        Email: Nargel@phoenixchildrens.com
CA
  • Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
    Contact Information:
        Marquez, Gonzalo
        Phone: (323) 361-5251
        Email: gmarquez@chla.usc.edu
CO
  • Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
    Contact Information:
        Pardee, Churee
        Phone: (720) 777-6162
        Email: churee.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@connecticutchildrens.org
  • Central Connecticut Cystic Fibrosis Center (Adult), Hartford, CT, 06107
    Contact Information:
        Trifiro, Sandra
        Phone: (860) 545-3416
        Email: sandra.trifiro@hhchealth.org
FL
  • University of Florida (Adult), Gainesville, FL, 32610
    Contact Information:
        Nichols, Wanda
        Phone: (352) 273-8732
        Email: nichowj@medicine.ufl.edu
  • 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), 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, 67214
    Contact Information:
        Miller, Sheri
        Phone: (316) 268-6028
        Email: Sheri.Miller@viachristi.org
MA
MI
  • Wayne State University Harper University Hospital (Adult), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
        Email: cvanwag@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@barnabashealth.org
  • 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: lisa.cerracchio@rutgers.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
  • Women and 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
  • Beth Israel Medical Center (Pediatric), New York, NY, 10003
    Contact Information:
        DiBenedetto, Donna
        Phone: (212) 420-4100
        Email: ddibenedetto@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) 594-2348
        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
  • 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
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:
        Sandman, Carmen
        Phone: (605) 312-0008
        Email: Carmen.Sandman@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:
        Buescher, Christine
        Phone: (757) 668-6416
        Email: bueschcr@evms.edu
  • Virginia Commonwealth University (Pediatric and Adult), 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:
        Aitken, Moira
        Phone: (206) 543-3166
        Email: moira@u.washington.edu
Back to top