CFF - 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

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Clinical Research Information Sheet

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:

Recruitment Status:

Recruiting

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:
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.

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

Tucson CF Center (Pediatric and Adult), Tucson, AZ, 85724
Contact Information:
    Molina, Osmara
    Phone: (520) 891-6767
    Email: omolina@arc.arizona.edu

University of California San Diego -Thornton (Adult), La Jolla, CA, 92037
Contact Information:
    Kwan, Doris
    Phone: (858) 657-7119
    Email: dlkwan@ucsd.edu
Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
Contact Information:
    Ortega, Ricardo
    Phone: (323) 361-6639
    Email: rortega@chla.usc.edu

National Jewish Health (Adult), Denver, CO, 80206
Contact Information:
    Jones, Marion
    Phone: (303) 398-1265
    Email: jonesm@njhealth.org

Alfred I. duPont Hospital for Children (Pediatric and Adult), Wilmington, DE, 19899
Contact Information:
    Budd, Sandra
    Phone: (302) 651-6536
    Email: sbudd@nemours.org

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: bdeluca@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:
    Kesser, Kenneth (Bert)
    Phone: (407) 650-7175
    Email: bkesser@nemours.org
Tampa General Hospital (Adult), Tampa, FL, 33606
Contact Information:
    Roberson, Suzanne
    Phone: (813) 844-7179
    Email: sroberson@tgh.org

Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
Contact Information:
    Richardson, Stacey
    Phone: (317) 948-7121
    Email: stlyrich@iupui.edu

University of Kansas Medical Center (Pediatric), Kansas City, KS, 66160
Contact Information:
    Liebergen, Adrienne
    Phone: (913) 588-6320
    Email: alieberg@kumc.edu

Children's Hospital Boston (Pediatric), Boston, MA, 02115
Contact Information:
    Leone Thakkallapalli, Erin
    Phone: (617) 355-3197
    Email: erin.leone@childrens.harvard.edu

Wayne State University Harper University Hospital (Adult), Detroit, MI, 48201
Contact Information:
    Cahill, James
    Phone: (313) 745-2221
    Email: jcahil@med.wayne.edu

Dartmouth Hitchcock Medical Center (Adult), Lebanon, NH, 03756
Contact Information:
    Moulton, Lisa
    Phone: (603) 650-8178
    Email: Lisa.A.Moulton@Hitchcock.ORG

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
SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
Contact Information:
    Lindner, Donna
    Phone: (315) 464-7525
    Email: lindnerd@upstate.edu

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

Drexel University College of Medicine (Adult), Philadelphia, PA, 19129
Contact Information:
    Hillman, Judy
    Phone: (215) 762-5462
    Email: jhillman@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

Medical University of South Carolina (Adult), Charleston, SC, 29425
Contact Information:
    Warden, Ashley
    Phone: (843) 792-4349
    Email: jonesash@musc.edu

University of Tennessee CF Care and Research Center (Pediatric), Memphis, TN, 38103
Contact Information:
    Culbreath, Barbara
    Phone: (901) 287-5351
    Email: bculbreath@uthsc.edu

Children's Medical Center of Dallas (Pediatric), Dallas, TX, 75235
Contact Information:
    Hebert, Andrew
    Phone: (214) 456-5618
    Email: andrew.hebert@childrens.com
Children's Medical Center of Dallas (Pediatric), Dallas, TX, 75235
Contact Information:
    Dunn-Richmond, Kate
    Phone: (214) 648-2817
    Email: Kate.dunn-richmond@utsouthwestern.edu

University of Virginia (Pediatric), Charlottesville, VA, 22908
Contact Information:
    Moss, Patricia
    Phone: (434) 243-2876
    Email: pcm2v@virginia.edu

Vermont Children's Hospital (Pediatric), Burlington, VT, 05401
Contact Information:
    Diehl, Sandra
    Phone: (802) 847-3884
    Email: Sandra.Diehl@uvm.edu

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