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Study Name: Arikace for Nontuberculous Mycobacteria (NTM)
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Insmed
Study Phase: 3
Recruitment Status: Recruiting Completed
Study Drug(s): Arikace
Number of Participants Being Recruited: 100
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
Nontuberculous mycobacteria (NTM) are organisms common in the soil and in environmental and potable water, and have been associated with lung disease in select patient groups. Treatment requires lengthy multi-drug regimens that can be poorly tolerated and are often not very effective, especially in patients with severe disease or in those who have failed prior treatment attempts. There have been very few clinical trials to support current treatment recommendations and no new drugs have been assessed for this disease in many years.

Amikacin is an established antibiotic that is effective against a variety of NTM. However, intravenous amikacin treatment is limited by its systemic route of administration. Arikace, liposomal amikacin for inhalation, is a sustained-release formulation of amikacin encapsulated inside very small liposomal carriers (fat particles) designed for administration via inhalation. This formulation allows for targeting the drug to the lungs and the site of disease. The purpose of this study is to determine whether Arikace is effective in treating recalcitrant nontuberculous mycobacterial lung disease. The safety and tolerability of Arikace in this patient population will also be assessed.
ELIGIBILITY
Age: 12 Years - 75 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Subjects must have active non-tuberculous mycobacterial lung disease. This study includes CF and non-CF patients.
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: Gupta, Renu
(732) 997-4526
rgupta@transaveinc.com
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT01315236?term=arikace+and+ntm&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.
AL
  • The Children's Hospital/University of Alabama at Birmingham (Pediatric), Birmingham, AL, 35233
    Contact Information:
        Hathorne, Heather
        Phone: (205) 638-9568
        Email: hhathorne@peds.uab.edu
FL
  • Tampa General Hospital (Adult), Tampa, FL, 33606
    Contact Information:
        Roberson, Suzanne
        Phone: (813) 844-7179
        Email: sroberson@tgh.org
KS
  • University of Kansas Medical Center (Pediatric), Kansas City, KS, 66160
    Contact Information:
        Liebergen, Adrienne
        Phone: (913) 588-6320
        Email: alieberg@kumc.edu
OH
  • 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
WI
  • Froedtert & Medical College of Wisconsin (Adult), Milwaukee, WI, 53201
    Contact Information:
        Harris, Rachel
        Phone: (414) 955-7030
        Email: racharris@mcw.edu
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