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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: 3
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.
AK
  • Providence Alaska Medical Center (Pediatric and Adult), Anchorage, AK, 99508
    Contact Information:
        Roberts, Vicki
        Phone: (907) 212-3299
        Email: vicki.roberts@providence.org
AZ
  • Tucson CF Center (Pediatric and Adult), Tucson, AZ, 85724
    Contact Information:
        Molina de Rodriguez, Osmara
        Phone: (520) 891-6767
        Email: omolina@email.arizona.edu
CA
  • 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:
        Marquez, Gonzalo
        Phone: (323) 361-5251
        Email: gmarquez@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:
        Kirk, Kaitlyn
        Phone: (916) 734-3351
        Email: kaitlyn.kirk@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
CO
  • Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
    Contact Information:
        Pardee, Churee
        Phone: (720) 777-6162
        Email: churee.pardee@childrenscolorado.org
  • National Jewish Health (Adult), Denver, CO, 80206
    Contact Information:
        Jones, Marion
        Phone: (303) 398-1265
        Email: jonesm@njhealth.org
CT
  • Central Connecticut Cystic Fibrosis Center (Pediatric), Hartford, CT, 06102
    Contact Information:
        Drapeau, Ginny
        Phone: (860) 545-9434
        Email: gdrapea@connecticutchildrens.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
  • 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
  • All Children's Hospital (Pediatric), St. Petersburg, FL, 33701
    Contact Information:
        Hosler, Kathy
        Phone: (727) 767-7247
        Email: kathy.hosler@jhmi.edu
  • 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
  • Lutheran General Children's Hospital (Pediatric), Park Ridge, IL, 60068
    Contact Information:
        Moen, Suellen
        Phone: (847) 738-7334
        Email: suellen.moen@advocatehealth.com
IN
  • Indiana University (Adult), Indianapolis, IN, 46202
    Contact Information:
        Puntenney, Paula
        Phone: (317) 274-1441
        Email: ppuntenn@iu.edu
  • Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
    Contact Information:
        Bendy, Lisa
        Phone: (317) 948-7152
        Email: lbendy@iupui.edu
KY
  • 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
LA
  • Tulane University (Pediatric), New Orleans, LA, 70112
    Contact Information:
        Gandolfo, Danielle
        Phone: (504) 988-6167
        Email: dgandol@tulane.edu
MA
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Correia, Catherine
        Phone: (617) 355-2446
        Email: Catherine.Correia@childrens.harvard.edu
  • Massachusetts General Hospital (Pediatric), Boston, MA, 02114
    Contact Information:
        Doolittle, Caitlin
        Phone: (617) 726-3719
        Email: cdoolittle1@partners.org
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
  • 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:
        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
MN
  • The Minnesota Cystic Fibrosis Center (Pediatric), Minneapolis, MN, 55455
    Contact Information:
        Grover, Patricia
        Phone: (612) 626-7425
        Email: Grove026@umn.edu
MO
  • 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:
        Cooper, Amy
        Phone: (314) 678-5457
        Email: acoope16@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
NC
  • 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
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
  • Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
    Contact Information:
        Marra, Bridget
        Phone: (732) 222-4474
        Email: bmarra@barnabashealth.org
  • Morristown Medical Center (Adult), Morristown, NJ, 07962
    Contact Information:
        Martinez, Nancy
        Phone: (973) 971-5138
        Email: nancy.martinez@atlantichealth.org
NY
  • 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:
        DiBenedetto, Donna
        Phone: (212) 420-4100
        Email: ddibenedetto@chpnet.org
  • 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) 594-2348
        Email: ingrid_gherson@nymc.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
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
  • Dayton Children's Hospital (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
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
  • University of South Carolina School of Medicine (Pediatric), Columbia, SC, 29203
    Contact Information:
        Turner, Carolyn
        Phone: (803) 784-7555
SD
  • Sanford Medical Center (Pediatric), Sioux Falls, SD, 57117
    Contact Information:
        Sandman, Carmen
        Phone: (605) 312-0008
        Email: Carmen.Sandman@SanfordHealth.org
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 University Medical Center (Adult), Nashville, TN, 37232
    Contact Information:
        Robinette, Michelle
        Phone: (615) 343-9025
        Email: michelle.robinette@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
  • 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
  • Children's Medical Center of Dallas (Pediatric), Dallas, TX, 75235
    Contact Information:
        Hebert, Andrew
        Phone: (214) 456-5618
        Email: andrew.hebert@childrens.com
  • 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
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
  • Children's Hospital of the King's Daughters (Pediatric), Norfolk, VA, 23507
    Contact Information:
        Buescher, Christine
        Phone: (757) 668-6416
        Email: bueschcr@evms.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
WA
  • 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:
        Aitken, Moira
        Phone: (206) 543-3166
        Email: moira@u.washington.edu
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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