Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
Status:
Not yet recruiting
Trial end date:
2027-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Kevin Winthrop
Collaborators:
Mayo Clinic Medical University of South Carolina National Center for Advancing Translational Sciences (NCATS) National Institute on Deafness and Other Communication Disorders (NIDCD) National Jewish Health Oricula Therapeutics The University of Texas Health Science Center at Tyler University of Washington