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Study Name: Inhaled Levofloxacin (MP-376) Pediatric Safety Study
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Mpex
Study Phase: 1
Recruitment Status: Trial Completed
Study Drug(s): Levofloxacin (Inhaled)
Number of Participants Being Recruited: 24
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
Patients 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 difficult to eliminate in CF patients. Aerosol delivery of antibiotics directly to the lung increases the amount of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration such as oral or intravenous methods. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung may have antimicrobial effects on even the most resistant organisms. MP-376 is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery using the PARI electronic eFlow® nebulizer.
ELIGIBILITY
Age: 6 Years - 16 Years
FEV1: 25 - 95 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
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: Loutit, Jeff
(858) 875-6665
jloutit@rempexpharma.com
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00840333?term=MPEX+and+cystic+fibrosis&rank=3
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.
CA
  • Rady Children's Hospital San Diego and Health Center at the University of California San Diego (Pediatric), San Diego, CA, 92123
    Contact Information:
        Holland, Sarah
        Phone: (858) 966-8153
        Email: sholland@rchsd.org
FL
  • Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
    Contact Information:
        Price, Angela
        Phone: (407) 650-7634
        Email: alprice@nemours.org
MI
  • Children's Hospital of Michigan (Pediatric), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
        Email: cvanwag@med.wayne.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
OH
  • Children's Hospital Medical Center of Akron (Pediatric), Akron, OH, 44308
    Contact Information:
        Ouellette, Deborah
        Phone: (330) 543-3089
        Email: douellette@chmca.org
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