ORC-13661 to protect hearing during IV amikacin treatment
Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Ototoxicity in Patients Receiving Intravenous Amikacin for Treatment of Non-Tuberculous Mycobacterium Infection
This project tests whether the oral drug ORC-13661 can protect adults receiving intravenous amikacin for non-tuberculous mycobacterial infections from hearing loss.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Oregon Health & Science University NIH-funded |
| Lab location | 1 site (Portland, United States) |
| Project ID | NIH-11143905 on NIH RePORTER |
What this research studies
If I am an adult being treated with IV amikacin for pulmonary or disseminated non-tuberculous Mycobacterium (NTM) infection, this project would give ORC-13661 by mouth alongside my antibiotic to try to prevent hearing damage. Participants will have regular hearing tests and safety monitoring during and after treatment to see if ORC-13661 reduces ototoxicity. ORC-13661 showed strong protection in animal studies and has completed Phase 1 safety testing in healthy volunteers, so this Phase 2 effort tests protection in patients. The work is led from Oregon Health & Science University and may involve visits to that site or other participating centers.
Who could benefit from this research
Good fit: Adults (age 21 and older) receiving intravenous amikacin for pulmonary or disseminated non-tuberculous Mycobacterium infections are the ideal candidates.
Not a fit: People not receiving aminoglycoside antibiotics, children under study age limits, or those with existing severe sensorineural hearing loss are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, ORC-13661 could prevent permanent hearing loss from aminoglycoside antibiotics and allow safer, more routine use of amikacin.
How similar studies have performed: Preclinical animal studies showed robust protection of hearing and Phase 1 trials demonstrated safety in healthy volunteers, but no FDA-approved drug yet prevents aminoglycoside-induced hearing loss in patients, so this approach is promising but not yet proven clinically.
Where this research is happening
Portland, United States
- Oregon Health & Science University — Portland, United States (Active)
Researchers
- Principal investigator: Winthrop, Kevin Loring — Oregon Health & Science University
- Study coordinator: Winthrop, Kevin Loring
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.