CFF - Levofloxacin Inhalation Solution (Aeroquinâ?¢) compared to placebo in people with Cystic Fibrosis

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Clinical Research Information Sheet

Study Name:

Levofloxacin Inhalation Solution (Aeroquinâ?¢) compared to placebo in people with Cystic Fibrosis

Study Type:

Interventional

Intervention Category:

Anti-Infective

Study Sponsor:

Mpex

Study Phase:

Recruitment Status:

Trial Completed

Study Drug(s):

Levofloxacin (Inhaled)

Number of Participants Being Recruited:

330

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

People with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. This study is a phase 3 placebo controlled trial that will look at the safety and effectiveness of an aerosolized form of the antibiotic, levofloxacin (AEROQUINâ?¢) , when given twice a day over 28 days. Clinical trial participants will receive either an aersolized placebo solution or the aersolized levofloxacin, Aeroquinâ?¢.

ELIGIBILITY

Age:	>= 12 Years
FEV1:	25 - 85 Percent Predicted
P. aeruginosa status:	Positive
B. cepacia status:	Not applicable
Other Primary Eligibility Requirements: Participants in the MPEX 204 study are not eligible for this study.
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/NCT01180634?term=mpex+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.

Providence Alaska Medical Center (Pediatric and Adult), Anchorage, AK, 99508
Contact Information:
    Roberts, Vicki
    Phone: (907) 212-3299
    Email: vicki.roberts@providence.org

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
Miller Children's Hospital (Pediatric), Long Beach, CA, 90801
Contact Information:
    O'Donnell, Nan
    Phone: (562) 933-5607
    Email: nodonnell@memorialcare.org
Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
Contact Information:
    Ortega, Ricardo
    Phone: (323) 361-6639
    Email: rortega@chla.usc.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
Kaiser Permanente Medical Care Program (Pediatric), Oakland, CA, 94611
Contact Information:
    Lee, Julie
    Phone: (510) 752-7558
    Email: julie.lee@kp.org
Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
Contact Information:
    Dunn, Colleen
    Phone: (650) 736-0388
    Email: cedunn@stanford.edu
University of California at Davis Medical Center (Adult), Sacramento, CA, 95817
Contact Information:
    O'Brien, Claire
    Phone: (916) 734-3351
    Email: claire.obrien@ucdmc.ucdavis.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

Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
Contact Information:
    Pardee, Churee
    Phone: (720) 777-6162
    Email: chureeporn.pardee@childrenscolorado.org
National Jewish Health (Adult), Denver, CO, 80206
Contact Information:
    Jones, Marion
    Phone: (303) 398-1265
    Email: jonesm@njhealth.org

Central Connecticut Cystic Fibrosis Center (Pediatric), Hartford, CT, 06102
Contact Information:
    Drapeau, Ginny
    Phone: (860) 545-9434
    Email: gdrapea@ccmckids.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

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
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

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

Saint Luke's Cystic Fibrosis Center of Idaho (Pediatric and Adult), Boise, ID, 83712
Contact Information:
    Durham, Dixie
    Phone: (208) 381-7334
    Email: durhamd@slhs.org

University of Chicago (Pediatric), Chicago, IL, 60637
Contact Information:
    Cheatham, Jeannine
    Phone: (773) 834-0192
    Email: jcheatham@peds.bsd.uchicago.edu
Lutheran General Children's Hospital (Pediatric), Park Ridge, IL, 60068
Contact Information:
    Moen, Suellen
    Phone: (847) 738-7334
    Email: suellen.moen@advocatehealth.com

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
University of Louisville (Pediatric), Louisville, KY, 40202
Contact Information:
    Tomazin, Janet
    Phone: (502) 852-3772
    Email: jmtoma01@louisville.edu

Tulane University (Pediatric), New Orleans, LA, 70112
Contact Information:
    Gandolfo, Danielle
    Phone: (504) 988-6167
    Email: dgandol@tulane.edu

Children's Hospital Boston (Pediatric), Boston, MA, 02115
Contact Information:
    Leone Thakkallapalli, Erin
    Phone: (617) 355-3197
    Email: erin.leone@childrens.harvard.edu
Massachusetts General Hospital (Pediatric), Boston, MA, 02114
Contact Information:
    Doolittle, Caitlin
    Phone: (617) 726-3719
    Email: cdoolittle1@partners.org

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

University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
Contact Information:
    Kruse, Dawn
    Phone: (734) 615-3266
    Email: dmkruse@umich.edu
Children's Hospital of Michigan (Pediatric), Detroit, MI, 48201
Contact Information:
    Van Wagnen, Catherine
    Phone: (313) 745-4737
    Email: cvanwag@med.wayne.edu
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

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

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

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

Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
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

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
Beth Israel Medical Center (Pediatric), New York, NY, 10003
Contact Information:
    Grece, Carroll Anne
    Phone: (212) 420-4196
    Email: cgrece@chpnet.org
Columbia University, Adult Cystic Fibrosis Program (Adult), New York City, NY, 10032
Contact Information:
    Robinson, Victoria
    Phone: (212) 305-0686
    Email: vgr2103@columbia.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

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:
    Johnson, Mary Terri
    Phone: (614) 722-4766
    Email: Terri.Johnson@nationwidechildrens.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
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

Medical University of South Carolina (Adult), Charleston, SC, 29425
Contact Information:
    Warden, Ashley
    Phone: (843) 792-4349
    Email: jonesash@musc.edu
University of South Carolina School of Medicine (Pediatric), Columbia, SC, 29203
Contact Information:
Turner, Carolyn
Phone: (803) 784-7555

Sanford Medical Center (Pediatric), Sioux Falls, SD, 57117
Contact Information:
    Hanson, Dawn
    Phone: (605) 312-1033
    Email: Dawn.Hanson@sanfordhealth.org

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 University Medical Center (Adult), Nashville, TN, 37232
Contact Information:
    Robinette, Michelle
    Phone: (615) 343-9025
    Email: michelle.robinette@vanderbilt.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
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
Cook Children's Medical Center (Pediatric), Fort Worth, TX, 76104
Contact Information:
    Morris, Trudy
    Phone: (682) 885-1244
    Email: Trudy.Morris@cookchildrens.org
Baylor College of Medicine (Pediatric), Houston, TX, 77030
Contact Information:
    Schaap, Nicoline
    Phone: (832) 822-4252
    Email: nxschaap@texaschildrens.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

Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
Contact Information:
    Vroom, Jane
    Phone: (801) 587-7458
    Email: jane.vroom@hsc.utah.edu

Children's Hospital of the King's Daughters (Pediatric), Norfolk, VA, 23507
Contact Information:
    Perkins, Susan
    Phone: (757) 668-6416
    Email: PerkinSR@evms.edu
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

Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
Contact Information:
    McNamara, Sharon
    Phone: (206) 987-3921 X1
    Email: sharon.mcnamara@seattlechildrens.org
University of Washington Medical Center (Adult), Seattle, WA, 98195
Contact Information:
    Wolfstone, Alycia
    Phone: (206) 685-3995
    Email: aewolf@u.washington.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

West Virginia University CF Center (Pediatric and Adult), Morgantown, WV, 26505
Contact Information:
    Collins, Sue
    Phone: (304) 293-7348
    Email: scollins@hsc.wvu.edu