Phase 2 Trial Testing ORC-13661 to Prevent Hearing Loss in Adults Receiving IV Amikacin for Nontuberculous Mycobacterium Infection

What this Trial Is About

This research aims to evaluate the effectiveness of the study drug ORC-13661 in preventing hearing loss caused by intravenous amikacin treatment in patients with nontuberculous mycobacteria NTM infection. NTM infections can lead to serious lung disease, especially in older adults, and amikacin is a common antibiotic used to treat severe cases but may cause damage to the inner ear leading to hearing and balance problems. This Phase 2, randomized, double-blind, placebo-controlled trial compares different doses of ORC-13661 to see if it can reduce or prevent this ototoxicity. Participants will be randomly assigned to one of three groups a high-dose ORC-13661 group, a low-dose ORC-13661 group, or a placebo group. Each participant will take the assigned study drug daily, starting with a loading dose followed by a maintenance dose, alongside their IV amikacin treatment. The study drug or placebo treatment will continue for up to 90 days or until the amikacin treatment ends, whichever occurs first. The trial will assess the safety and effects of these treatments in preventing hearing loss. During the study, participants will be monitored through clinical assessments to track hearing ability, speech perception, balance, and quality of hearing. Researchers will collect data from the beginning of treatment until 28 days after stopping the study drug or after 90 days of treatment, whichever comes first. Participants will be asked to follow study procedures and attend visits to allow thorough evaluation of hearing outcomes and safety throughout the trials duration.

Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin