CFF - Inhaled Ciprofloxacin for People with CF and Pseudomonas aeruginosa

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Clinical Research Information Sheet

Study Name:

Inhaled Ciprofloxacin for People with CF and Pseudomonas aeruginosa

Study Type:

Interventional

Intervention Category:

Anti-Infective

Study Sponsor:

Bayer

Study Phase:

Recruitment Status:

Trial Completed

Study Drug(s):

Ciprofloxacin DPI

Number of Participants Being Recruited:

276

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

This study will look at the safety and effect of ciprofloxacin given as a inhaled medication in CF patients with P. aeruginosa over a 28 day time period.

ELIGIBILITY

Age:	>= 12 Years
FEV1:	35 - 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:

Clinical Trials Contact, Bayer
(888) 842-2937 X3
clinical-trials-contact@bayerhealthcare.com

Trial Specific Link on ClinicalTrials.gov:

http://clinicaltrials.gov/ct2/show/NCT00645788?term=Bayer+12429+and+cystic+fibrosis&rank=1

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.

University of Arkansas for Medical Sciences (Adult), Little Rock, AR, 72205
Contact Information:
    Taggart, Adam
    Phone: (501) 416-7019
    Email: agtaggart@uams.edu

Phoenix Children's Hospital (Pediatric), Phoenix, AZ, 85016
Contact Information:
    Argel, Natalia
    Phone: (602) 546-0343
    Email: nargel@phoenixchildrens.com
Tucson CF Center (Pediatric and Adult), Tucson, AZ, 85724
Contact Information:
    Molina, Osmara
    Phone: (520) 891-6767
    Email: omolina@arc.arizona.edu

USC Keck School of Medicine (Adult), Los Angeles, CA, 90033
Contact Information:
    Fukushima, Lynn
    Phone: (323) 442-5869
    Email: lynn.fukushima@med.usc.edu
University of California at San Francisco (Adult), San Francisco, CA, 94143
Contact Information:
    Moreno, Courtney
    Phone: (415) 476-2984
    Email: morenoc@peds.ucsf.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 (Adult), Miami, FL, 33136
Contact Information:
    Mendes, Eliana
    Phone: (305) 243-2568
    Email: emendes@med.miami.edu
Central Florida Pulmonary Group (Adult), Orlando, FL, 32803
Contact Information:
    Chemtob, Candace
    Phone: (407) 383-4308
    Email: chemtob@earthlink.net
Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
Contact Information:
    Kesser, Kenneth (Bert)
    Phone: (407) 650-7175
    Email: bkesser@nemours.org

Georgia Health Sciences University (Adult), Augusta, GA, 30912
Contact Information:
    Weathers, Charlene
    Phone: (706) 721-9546
    Email: chweathers@georgiahealth.edu

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
Rush University Medical Center (Pediatric), Chicago, IL, 60612
Contact Information:
    Burke, Jenifer
    Phone: (312) 563-2273
    Email: Jenifer_Burke@rush.edu

Indiana University (Adult), Indianapolis, IN, 46202
Contact Information:
    Richardson, Stacey
    Phone: (317) 948-7121
    Email: stlyrich@iupui.edu
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 Kentucky (Pediatric), Lexington, KY, 40536
Contact Information:
    Watts, Tammy
    Phone: (859) 257-5087
    Email: twatt2@uky.edu

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

University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
Contact Information:
    Kruse, Dawn
    Phone: (734) 615-3266
    Email: dmkruse@umich.edu
Western Michigan University School of Medicine Clinics (Pediatric and Adult), Kalamazoo, MI, 49008
Contact Information:
Sheppard, Sandra
Phone: (269) 337-6471

University of Mississippi Medical Center (Pediatric), Jackson, MS, 39216
Contact Information:
    Adcock, Kim
    Phone: (601) 815-9172
    Email: kadcock@umc.edu

Duke University Medical Center (Pediatric), Durham, NC, 27710
Contact Information:
    Auten, Kathy
    Phone: (919) 684-2281
    Email: kathy.auten@duke.edu

Monmouth Medical Center (Adult), Long Branch, NJ, 07724
Contact Information:
    Marra, Bridget
    Phone: (732) 222-4474
    Email: bmarra@sbhcs.com
Goryeb Children's Hospital of Atlantic Health (Adult), Morristown, NJ, 07962
Contact Information:
    Cahill, Carol
    Phone: (973) 971-5138
    Email: carol.cahill@atlantichealth.org

Adult Cystic Fibrosis Center - Southern Nevada (Adult), Las Vegas, NV, 89107
Contact Information:
McGinley, Cynthia
Phone: (702) 598-4411

Albany Medical College (Adult), Albany, NY, 12208
Contact Information:
    Mokhiber, Katharine
    Phone: (518) 262-6608
    Email: mokhibk@mail.amc.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

Children's Hospital Medical Center of Akron (Adult), Akron, OH, 44308
Contact Information:
    Ouellette, Deborah
    Phone: (330) 543-3089
    Email: douellette@chmca.org
University of Cincinnati Medical Center (Adult), Cincinnati, OH, 45267
Contact Information:
    Roads, Tammy
    Phone: (513) 558-2148
    Email: roadst@ucmail.uc.edu
Northwest Ohio Cystic Fibrosis Center (Adult), Toledo, OH, 43606
Contact Information:
    Houser, Kelly
    Phone: (419) 291-4630
    Email: kelly.houser@promedica.org

Oklahoma Cystic Fibrosis Center (Pediatric), Oklahoma City, OK, 73104
Contact Information:
    Fox, Jodie
    Phone: (405) 271-6216
    Email: Jodie-Fox@ouhsc.edu

Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
Contact Information:
    Kitch, Diane
    Phone: (717) 531-5646
    Email: dkitch@psu.edu
St. Christopher's Hospital for Children (Pediatric), Philadelphia, PA, 19134
Contact Information:
    Aramburo, Marcella
    Phone: (215) 427-3816
    Email: Marcella.aramburo@drexelmed.edu
University of Pennsylvania Hospital (Adult), Philadelphia, PA, 19104
Contact Information:
    Kubrak, Christina
    Phone: (267) 426-5135
    Email: kubrak@email.chop.edu

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

Dell Children's Medical Center of Central Texas (Pediatric and Adult), Austin, TX, 78723
Contact Information:
    Brazil, Isolde
    Phone: (512) 380-9200 X206
    Email: IBrazil@accapa.com
Christus Santa Rose Children's Hospital (Adult), San Antonio, TX, 78212
Contact Information:
    Phillips, Teresa
    Phone: (210) 223-3010
    Email: tphillips@acra-sa.com

Intermountain Cystic Fibrosis Center (Adult), Salt Lake City, UT, 84132
Contact Information:
    Packer, Kristyn
    Phone: (801) 585-0401
    Email: kristyn.packer@hsc.utah.edu

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

Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
Contact Information:
    McNamara, Sharon
    Phone: (206) 987-3921 X1
    Email: sharon.mcnamara@seattlechildrens.org

University of Wisconsin (Adult), Madison, WI, 53792
Contact Information:
    Stevens, Chiron (Sophia)
    Phone: (608) 263-1244
    Email: scstevens@medicine.wisc.edu