Condition: Ototoxicity, Drug-Induced · Sponsor: Kevin Winthrop
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.
This description comes directly from the study's public registry record.
Daniel Bouchat · 503-494-2568 · johdanie@ohsu.edu
Violet Tiffee · 503-494-1433 · tiffee@ohsu.edu
Always discuss trial participation with your own doctor first.
| University of California, San Francisco | San Francisco, California, United States | Recruiting |
| National Jewish Health | Denver, Colorado, United States | Recruiting |
| Johns Hopkins University | Baltimore, Maryland, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| Northwell Health | Manhasset, New York, United States | Recruiting |
| Oregon Health & Science University | Portland, Oregon, United States | Recruiting |
| Medical University of South Carolina | Charleston, South Carolina, United States | Recruiting |
| University of Texas Health Science Center | Tyler, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05730283