Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
ConditionOtotoxicity, Drug-Induced
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKevin Winthrop
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Providing informed consent, documented by signing and dating the currently valid informed consent form.
Considered by the Investigator to have unimpaired consent capacity, without reliance on a legally authorized representative.
Stated willingness and ability to comply with study procedures and availability for the duration of the study.
Aged > 18 and < 80.
Disqualifiers
Received a systemic aminoglycoside antibiotic within 6 months prior to planned first dose of amikacin.
ECG at Screening or prior to randomization (mean of triplicate values) with QT interval corrected using Fridericia's formula (QTcF interval) ≥ 450 msec.
ECG at Screening or prior to randomization with abnormalities that, in the Investigator's judgment, might predispose patient to clinically significant arrhythmia.
Patients taking strong CYP3A4 inducers such as rifampin and rifabutin in the 7 days prior to randomization or have the need for ongoing treatment with concomitant oral or intravenous therapy with strong CYP3A4 inducers during the study. If an additional antibiotic is needed, then azithromycin will be used.
Trial design
Design model
Parallel
Treatments tested in this trial
ORC-13661
DrugHigh-dose intervention (30mg daily)
ORC-13661
DrugLow-dose intervention (12mg daily)
Placebo
DrugPlacebo intervention
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: High Dose ORC-13661Experimental treatment 1 intervention
Group B: Low Dose ORC-13661Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mitigation or Prevention of Ototoxicity
Outcome is measured by changes from baseline using the American Speech-Language-Hearing Association (ASHA) shift criterion in patients with NTM disease undergoing treatment with IV amikacin therapy
Time frame
Baseline to 28 (±5) days after study treatment discontinuation or 28 days after 90 days of study treatment, whichever comes first.Secondary outcomes
1
Mitigation or Prevention of hearing impairment with regards to speech perceptions
Outcome is measured by changes to patient's speech perceptions using the High Frequency Digits-in-Noise (HF-DIN) test
Time frame
Baseline to 28 (±5) days after study treatment discontinuation or 28 days after 90 days of study treatment, whichever comes first.2
Mitigation or Prevention of hearing impairment with regards to perceived auditory and balance effects
Outcome is measured by changes to patient's tinnitus using the Modified-Tinnitus Ototoxicity Monitoring Interview (TOMI)
Time frame
Baseline to 28 (±5) days after study treatment discontinuation or 28 days after 90 days of study treatment, whichever comes first.3
Mitigation or Prevention of hearing impairment with regards to speech, spatial and quality of hearing
Outcome is measured by changes to patient's Speech, Spatial and Quality of Hearing Scale (SSQ12)
Time frame
Baseline to 28 (±5) days after study treatment discontinuation or 28 days after 90 days of study treatment, whichever comes first.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kevin Winthrop
Lead sponsor
Oregon Health and Science University
Sponsor institution
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Oricula Therapeutics
Collaborator
University of Washington
Collaborator
National Jewish Health
Collaborator
Mayo Clinic
Collaborator
The University of Texas Health Science Center at Tyler
Collaborator
Medical University of South Carolina
Collaborator
University of California, San Francisco
Collaborator
Johns Hopkins University
Collaborator
Northwell Health
Collaborator
Source ClinicalTrials.gov