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Potential New Medication for Hearing Loss from Antibiotic Use

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Trial Objectives


People infected with non-tuberculous mycobacteria (NTM) often need intravenous (IV) antibiotic treatment. One of the most common of these treatments involves the antibiotic amikacin. Amikacin is an effective treatment for NTM, but it can cause hearing loss, which significantly impacts a person’s quality of life. Researchers are investigating a new medication called ORC-13661 to determine if it can prevent or lessen hearing loss in NTM patients who are being treated with amikacin that is administered by IV.

In this study, volunteers will be randomly assigned to receive either different doses of the study medication or a placebo (a medication containing no active ingredient). At clinic visits, volunteers will be asked to complete questionnaires about their health, receive physical and hearing exams, and undergo additional hearing tests.
 

Who Can Participate


Adults 18 to 80 years old who are starting intravenous (IV) treatment of amikacin for a nontuberculous mycobacterial infection (NTM).

Age: 18-80 Gender: Any

Estimated Time Commitment


Up to 10 visits over a maximum of 129 days (roughly 3 months)

Payment & Reimbursement


Payment: Provided

Travel Reimbursement: Not Available

Trial Contact


For more information, contact:

Cynthia Wainscoat
303.398.1259

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Trial Location


National Jewish Main Campus, Denver, CO

Trial Sponsors


Charles Daley, MD

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