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Study Name: Aztreonam for Inhalation Solution (AZLI) taken in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas aeruginosa lung infections in people with CF
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Gilead
Study Phase: 4
Recruitment Status: Recruiting Completed
Study Drug(s): Cayston
Number of Participants Being Recruited: 250
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
Using a Continuous Alternating Therapy (CAT)regimen of 2 antibiotics of different classes with different mechanisms of action may provide the clinical benefits of reducing acute exacerbations, maintaining lung function and controlling respiratory symptoms for people with CF while minimizing the risk of emergence of antibiotic-resistant Pseudomonas aeruginosa (PA) strains.
ELIGIBILITY
Age: >= 6 Years
FEV1: 25 - 75 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

History of at least 1 hospitalization or 1 course of intravenous (IV) antibiotics for an acute respiratory exacerbation within the previous 12 months from Screening
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:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01641822
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
  • University of California San Diego -Thornton (Adult), La Jolla, CA, 92037
    Contact Information:
        Shaw, Kevin
        Phone: (858) 657-7119
        Email: kdshaw@ucsd.edu
  • Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
    Contact Information:
        Vajda, Natalie
        Phone: (323) 361-3255
        Email: nvajda@chla.usc.edu
  • Kaiser Permanente Medical Care Program (Pediatric), Oakland, CA, 94611
    Contact Information:
        Lee, Julie
        Phone: (510) 752-7558
        Email: julie.lee@kp.org
CO
  • National Jewish Health (Adult), Denver, CO, 80206
    Contact Information:
        Jones, Marion
        Phone: (303) 398-1265
        Email: jonesm@njhealth.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
  • University of Florida (Adult), Gainesville, FL, 32610
    Contact Information:
        Nichols, Wanda
        Phone: (352) 273-8732
        Email: nichowj@medicine.ufl.edu
  • Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
    Contact Information:
        DeLuca, Elizabeth
        Phone: (904) 697-3804
        Email: Elizabeth.DeLuca@nemours.org
  • University of Miami (Pediatric), Miami, FL, 33136
    Contact Information:
        Mendes, Eliana
        Phone: (305) 243-2568
        Email: emendes@med.miami.edu
  • Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
    Contact Information:
        Price, Angela
        Phone: (407) 650-7634
        Email: alprice@nemours.org
  • Tampa General Hospital (Adult), Tampa, FL, 33606
    Contact Information:
        Roberson, Suzanne
        Phone: (813) 844-7179
        Email: sroberson@tgh.org
GA
  • Emory University (Pediatric), Atlanta, GA, 30322
    Contact Information:
        Hunter, Eric
        Phone: (404) 785-3102
        Email: eahunte@emory.edu
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
  • University of Chicago (Pediatric), Chicago, IL, 60637
    Contact Information:
        Cheatham, Jeannine
        Phone: (773) 834-0192
        Email: jcheatham@peds.bsd.uchicago.edu
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
KS
  • University of Kansas Medical Center (Pediatric), Kansas City, KS, 66160
    Contact Information:
        Liebergen, Adrienne
        Phone: (913) 588-6320
        Email: alieberg@kumc.edu
MA
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
  • Wayne State University Harper University Hospital (Adult), 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
MO
  • 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
  • Duke University Medical Center (Pediatric), Durham, NC, 27710
    Contact Information:
        West, Miranda
        Phone: (919) 684-2281
        Email: miranda.west@duke.edu
NE
  • University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
    Contact Information:
        Acquazzino, Diane
        Phone: (402) 559-6275
        Email: dracquaz@unmc.edu
  • University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
    Contact Information:
        Telfer, Raquel
        Phone: (402) 559-6275
        Email: raquel.telfer@unmc.edu
NH
  • Dartmouth Hitchcock Medical Center (Pediatric), Lebanon, NH, 03756
    Contact Information:
        Moulton, Lisa
        Phone: (603) 650-8178
        Email: Lisa.A.Moulton@Hitchcock.ORG
NJ
  • Morristown Medical Center (Adult), Morristown, NJ, 07962
    Contact Information:
        Martinez, Nancy
        Phone: (973) 971-5138
        Email: nancy.martinez@atlantichealth.org
NY
  • 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
  • Children's Hospital of New York Columbia University (Pediatric), New York City, NY, 10032
    Contact Information:
        Kattan, Meyer
        Phone: (212) 305-5122
        Email: mk2833@columbia.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
  • University of Cincinnati Medical Center (Adult), Cincinnati, OH, 45267
    Contact Information:
        Roads, Tammy
        Phone: (513) 558-2148
        Email: roadst@ucmail.uc.edu
  • University of Cincinnati Medical Center (Adult), Cincinnati, OH, 45267
    Contact Information:
        Jerkins, Traci
        Phone: (513) 558-2079
        Email: stamatti@ucmail.uc.edu
  • 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
  • Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
    Contact Information:
        Kitch, Diane
        Phone: (717) 531-5646
        Email: dkitch@psu.edu
  • Drexel University College of Medicine (Adult), Philadelphia, PA, 19129
    Contact Information:
        Hillman, Judy
        Phone: (215) 762-5462
        Email: jhillman@drexelmed.edu
  • University of Pennsylvania Hospital (Adult), Philadelphia, PA, 19104
    Contact Information:
        Kubrak, Christina
        Phone: (267) 426-5135
        Email: kubrak@email.chop.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
SC
  • Medical University of South Carolina (Adult), Charleston, SC, 29425
    Contact Information:
        Warden, Ashley
        Phone: (843) 792-4349
        Email: jonesash@musc.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
  • Dell Children's Medical Center of Central Texas (Pediatric and Adult), Austin, TX, 78723
    Contact Information:
        Brazil, Isolde
        Phone: (512) 380-9200 X65343
        Email: IBrazil@seton.org
  • University of Texas Southwestern Medical Center/ St. Paul University Hospital (Adult), Dallas, TX, 75390
    Contact Information:
        Keller, Ashley
        Phone: (214) 648-2817
        Email: Ashley.Keller@UTSouthwestern.edu
  • University of Texas Southwestern Medical Center/ St. Paul University Hospital (Adult), Dallas, TX, 75390
    Contact Information:
        Dunn-Richmond, Kate
        Phone: (214) 648-2817
        Email: Kate.dunn-richmond@utsouthwestern.edu
  • Cook Children's Medical Center (Pediatric), Fort Worth, TX, 76104
    Contact Information:
        Morris, Trudy
        Phone: (682) 885-1244
        Email: Trudy.Morris@cookchildrens.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
  • Virginia Commonwealth University (Pediatric), Richmond, VA, 23235
    Contact Information:
        Ward, Matthew
        Phone: (804) 628-3093
        Email: wardmt@vcu.edu
VT
  • Vermont Children's Hospital (Pediatric), Burlington, VT, 05401
    Contact Information:
        Lippmann, Joan
        Phone: (802) 847-6982
        Email: joan.lippmann@vtmednet.org
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
WV
  • West Virginia University CF Center (Pediatric and Adult), Morgantown, WV, 26505
    Contact Information:
        Collins, Sue
        Phone: (304) 293-7348
        Email: scollins@hsc.wvu.edu
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