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
Kevin Winthrop
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.
Description
Nontuberculous mycobacteria (NTM) are environmental bacteria that can cause chronic, debilitating pulmonary disease, primarily affecting those over age 60. In more severe cases of NTM infection, patients are given a therapy with parenteral aminoglycoside antibiotics (AGs), to achieve control or cure. Amikacin is the most commonly used aminoglycoside for treatment in this setting, however it is limited by in its use by its tendency to cause ototoxicity including hearing loss and/or vestibular dysfunction. Ototoxicity refers to substances (i.e. medications) which are damaging to the inner ear se…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Providing informed consent, documented by signing and dating the currently valid informed consent form. 2. Considered by the Investigator to have unimpaired consent capacity, without reliance on a legally authorized representative. 3. Stated willingness and ability to comply with study procedures and availability for the duration of the study. 4. Aged \> 18 and \< 80. 5. NTM infection meeting current Pulmonary NTM guidelines from the American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) for systemic (IV) aminoglycoside therapy. 6. Anticipat…
Interventions
- DrugORC-13661
High-dose intervention (30mg daily)
- DrugORC-13661
Low-dose intervention (12mg daily)
- DrugPlacebo
Placebo intervention
Locations (7)
- University of California, San FranciscoSan Francisco, California
- National Jewish HealthDenver, Colorado
- Johns Hopkins UniversityBaltimore, Maryland
- Mayo ClinicRochester, Minnesota
- Oregon Health & Science UniversityPortland, Oregon
- Medical University of South CarolinaCharleston, South Carolina