Preventing hearing loss in patients treated with certain antibiotics
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 study is testing a new medication called ORC-13661 to see if it can help prevent hearing loss in people who need to take certain antibiotics for serious infections, especially those with non-tuberculous mycobacterial infections, and we want to make sure it's safe and effective for them.
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-10900457 on NIH RePORTER |
What this research studies
This research investigates the use of ORC-13661, a new medication designed to prevent hearing loss in patients receiving aminoglycoside antibiotics, which are often necessary for treating serious infections. The study aims to determine the efficacy and safety of ORC-13661 in patients who are at risk of hearing loss due to prolonged antibiotic therapy. By focusing on patients with non-tuberculous mycobacterial infections, the research seeks to provide a solution for those who require long-term treatment with these antibiotics. Participants will be monitored for any changes in hearing and overall health during the trial.
Who could benefit from this research
Good fit: Ideal candidates for this research are adults receiving intravenous aminoglycoside antibiotics for non-tuberculous mycobacterial infections.
Not a fit: Patients who are not receiving aminoglycoside antibiotics or those with conditions unrelated to antibiotic treatment may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could significantly reduce the incidence of hearing loss in patients treated with aminoglycoside antibiotics.
How similar studies have performed: Previous research has shown promising results in preventing hearing loss with similar approaches, but this specific treatment is novel and has not yet been widely tested.
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.