Actively Recruiting
Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
Led by Kevin Winthrop · Updated on 2026-05-07
105
Participants Needed
7
Research Sites
143 weeks
Total Duration
On this page
Sponsors
K
Kevin Winthrop
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent by signing the consent form.
- Have the ability to give consent without needing a legal representative.
- Willing and able to follow study procedures and be available for the entire study.
- Aged over 18 and under 80 years old.
- Diagnosed with NTM infection requiring intravenous aminoglycoside therapy.
- Expected to receive IV amikacin treatment for at least 30 days.
- Able to take oral medication and follow daily dosing instructions.
- Female participants of childbearing potential must agree to use effective double barrier contraception or abstinence from consent until 1 month after study drug ends.
- Male participants of reproductive potential must agree to use effective barrier contraception or abstinence from consent until 3 months after the last study drug dose.
You will not qualify if you...
- Received systemic aminoglycoside antibiotics within 6 months before starting amikacin.
- QTcF interval of 450 msec or more on ECG before randomization.
- ECG abnormalities that increase risk of significant arrhythmia.
- Use of strong CYP3A4 inducers (e.g., rifampin, rifabutin) or inhibitors (e.g., clarithromycin) within 7 days before randomization or planned during the study.
- Use of clofazimine or bedaquiline with certain heart conditions or abnormal ECG findings.
- Known resistance to amikacin.
- Progressive liver disease (Child-Pugh B or C).
- Ear conditions such as chronic eardrum perforation or inflammation.
- History of congenital hearing loss, ear surgery (except healed simple procedures), sudden hearing loss, or Meniere's disease.
- Bilateral profound hearing loss over 90 dB at all test frequencies.
- Conductive hearing loss with average air-bone gap over 15 dB HL.
- Active or untreated malignancy.
- History of risk factors for Torsades de Pointes.
- Inadequate venous access for study procedures.
- Any condition or finding that might interfere with the study or pose unreasonable risk.
- Current or planned use of excluded medications.
- Pregnancy or lactation.
- Female of childbearing potential without negative pregnancy test or contraceptive agreement.
- Female relying on menopause for contraception without consistent hormone levels or contraceptive agreement.
- Currently under correctional supervision (imprisoned, on probation, or parole).
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
3
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Not Yet Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
6
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
7
University of Texas Health Science Center
Tyler, Texas, United States, 75708
Actively Recruiting
Research Team
D
Daniel Bouchat
CONTACT
A
Alyssa Schroeder
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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