Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy. The main question this study aims to answer is: * Is ORC-13661 effective for preventing or lessening hearing loss induced by amikacin treatment? * Is ORC-13661 effective for preventing or lessening other measures of hearing impairment? Participants will be asked to take a study drug while they are being treated with IV amikacin. Participants will take study drug for 90 days or until the end of their amikacin treatment, whichever comes first. During this time, researchers will gather clinical data on the participants' health. Researchers will compare three groups - two groups taking different doses of the study drug and one group taking a placebo drug - to see if dose of drug has any effect on preventing hearing loss. A placebo is a look-alike substance that contains no active drug.

NCT Number	NCT05730283
Lead Sponsor	Kevin Winthrop Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), National Center for Advancing Translational Sciences (NCATS), Oricula Therapeutics, University of Washington, National Jewish Health, Mayo Clinic, The University of Texas Health Science Center at Tyler, Medical University of South Carolina, University of California, San Francisco, Johns Hopkins University, Northwell Health
Conditions	Ototoxicity, Drug-Induced
Enrollment	105 participants
Start Date	2025-06-02
Primary Completion	2028-02-29 (estimated)
Study Completion	2028-02-29 (estimated)
Updated on ClinicalTrials.gov	2026-07-14