Clinical trialNCT05730283RecruitingPhase 2Interventional

Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

SponsorKevin WinthropEnrollment105Ototoxicity, Drug-Induced

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Edwin Rubel, PhD
Oricula Therapeutics
Principal Investigator
clinicaltrials.gov ↗
Kevin L Winthrop, MD, MPH
Oregon Health and Science University
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California, San Francisco
San Francisco, California, United States
Catherine DeVoe, MDShoshana Zha, MD, PhD
Recruiting
National Jewish Health
Denver, Colorado, United States
Charles L Daley, MD
Recruiting
Johns Hopkins University
Baltimore, Maryland, United States
Elisa Ignatius, MD, MSc
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Timothy Aksamit, MD
Recruiting
Northwell Health
Manhasset, New York, United States
Lisa Hayes, MDMarcia Epstein, MD
Recruiting
Oregon Health & Science University
Portland, Oregon, United States
Kevin Winthrop, MD, MPH
Recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Patrick Flume, MD
Recruiting
University of Texas Health Science Center
Tyler, Texas, United States
Devanshi Mehta, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ORC-13661Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Jun 2025
Primary completion: 29 Feb 2028
Completion: 29 Feb 2028
Last update posted: 14 Jul 2026
Registered enrollment: 105
Registry id: NCT05730283

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.