CFF - KB001A in People with CF and Pseudomonas Aeruginosa

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Clinical Research Information Sheet

Study Name:

KB001A in People with CF and Pseudomonas Aeruginosa

Study Type:

Interventional

Intervention Category:

Anti-Inflammatory

Study Sponsor:

Kalobios

Study Phase:

Recruitment Status:

Recruiting

Study Drug(s):

KB001A

Number of Participants Being Recruited:

180

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

The purpose of this trial is to to evaluate the effect of KB001A on time - to - need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo in people with CF who have chronic Pseudomonas aeruginosa (Pa) lung infection. Study participants will be randomized to receive 5 IV infusions of either study drug or placebo. Sputum specimens of blood, sputum, and urine will be taken during the trial as well as pulmonary lung function testing performed. This trial will last up to 22 weeks.

ELIGIBILITY

Age:	12 Years - 50 Years
FEV1:	40 - 80 Percent Predicted
P. aeruginosa status:	Positive
B. cepacia status:	Negative
Other Primary Eligibility Requirements: Within the 6 months, prior to screening eligible subjects will have rec'd at least three 28 day courses of treatment with inhaled tobramycin or aztreonam.
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/show/NCT01695343

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

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

Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
Contact Information:
    Dunn, Colleen
    Phone: (650) 736-0388
    Email: cedunn@stanford.edu

Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
Contact Information:
    Pardee, Churee
    Phone: (720) 777-6162
    Email: chureeporn.pardee@childrenscolorado.org

University of Florida (Adult), Gainesville, FL, 32610
Contact Information:
    Nichols, Wanda
    Phone: (352) 273-8732
    Email: nichowj@medicine.ufl.edu
University of Miami (Pediatric), Miami, FL, 33136
Contact Information:
    Mendes, Eliana
    Phone: (305) 243-2568
    Email: emendes@med.miami.edu
Tampa General Hospital (Adult), Tampa, FL, 33606
Contact Information:
    Roberson, Suzanne
    Phone: (813) 844-7179
    Email: sroberson@tgh.org

Emory University (Pediatric), Atlanta, GA, 30322
Contact Information:
    Hunter, Eric
    Phone: (404) 727-9960
    Email: eahunte@emory.edu

University of Iowa (Pediatric), Iowa City, IA, 52242
Contact Information:
    Teresi, Mary
    Phone: (319) 384-7546
    Email: mary-teresi@uiowa.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

Maine Medical Partners Pediatric Specialty Care (Pediatric), Portland, ME, 04102
Contact Information:
    Milliard, Carrie
    Phone: (207) 662-6712
    Email: millic@mmc.org

Wayne State University Harper University Hospital (Adult), Detroit, MI, 48201
Contact Information:
    Cahill, James
    Phone: (313) 745-2221
    Email: jcahil@med.wayne.edu
Helen DeVos Women and Children's Center (Pediatric), Grand Rapids, MI, 49503
Contact Information:
    Symington, Thomas
    Phone: (616) 391-9366
    Email: thomas.symington@spectrumhealth.org

The Minnesota Cystic Fibrosis Center (Pediatric), Minneapolis, MN, 55455
Contact Information:
    Grover, Patricia
    Phone: (612) 626-7425
    Email: Grove026@umn.edu

The Children's Mercy Hospital (Pediatric and Adult), Kansas City, MO, 64108
Contact Information:
    Schmoll, Candy
    Phone: (816) 701-1339
    Email: cschmoll@cmh.edu
Cardinal Glennon Children's Medical Center (St. Louis University) (Pediatric), St. Louis, MO, 63104
Contact Information:
    Kociela, Vikki
    Phone: (314) 577-5608
    Email: kocielav@slu.edu
Washington University School of Medicine (Adult), St. Louis, MO, 63110
Contact Information:
    Burks, Patricia
    Phone: (314) 454-5175
    Email: Burks_P@kids.wustl.edu

Albany Medical College (Adult), Albany, NY, 12208
Contact Information:
    Mokhiber, Katharine
    Phone: (518) 262-6608
    Email: mokhibk@mail.amc.edu
Albany Medical College (Pediatric), Albany, NY, 12208
Contact Information:
    Evans, Terese
    Phone: (518) 262-5293
    Email: evansmt@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
New York Medical College/Westchester Medical Center (Pediatric), Valhalla, NY, 10595
Contact Information:
    Gherson, Ingrid
    Phone: (914) 594-3320
    Email: ingrid_gherson@nymc.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
University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
Contact Information:
    Ksenich, Roberta (Bobbi)
    Phone: (216) 844-5733
    Email: Roberta.Ksenich@UHHospitals.org
The Children's Medical Center of Dayton (Pediatric), Dayton, OH, 45404
Contact Information:
    Bartosik, Sandy
    Phone: (937) 641-4004
    Email: bartosiks@childrensdayton.org
Toldeo Children's Hospital (Pediatric), 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
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

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
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
Christus Santa Rose Children's Hospital (Adult), San Antonio, TX, 78212
Contact Information:
    Phillips, Teresa
    Phone: (210) 223-3010
    Email: tphillips@acra-sa.com

Virginia Commonwealth University (Pediatric), Richmond, VA, 23235
Contact Information:
    Ward, Matthew
    Phone: (804) 628-3093
    Email: wardmt@vcu.edu

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

University of Wisconsin (Pediatric), Madison, WI, 53792
Contact Information:
    Makholm, Linda
    Phone: (608) 262-0340
    Email: Lmakholm@uwhealth.org
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
Froedtert & Medical College of Wisconsin (Adult), Milwaukee, WI, 53201
Contact Information:
    Harris, Rachel
    Phone: (414) 955-7030
    Email: racharris@mcw.edu