Phase 2Recruiting

Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin Therapy for Non-Tuberculous Mycobacterium Disease

Sponsor
Kevin Winthrop (Academic or other)
Enrolment
105 planned
Conditions
Ototoxicity, Drug-Induced
Interventions
ORC-13661; ORC-13661; Placebo
Ages
adults, older adults
Registry
NCT05730283

From the registry

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.

Primary outcomes

  • Mitigation or Prevention of Ototoxicity
Full record on ClinicalTrials.gov