BridgeMD
Prevention study for Ototoxicity, Drug-Induced
Official title Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
ClinicalTrials.gov ID: NCT05730283
What this study is testing
What is ORC-13661?
ORC-13661 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ototoxicity, drug-induced.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
- NTM infection meeting current Pulmonary NTM guidelines from the American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA)...
You likely can't join if
- 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...
- ECG at Screening or prior to randomization with abnormalities that, in the Investigator's judgment, might predispose patient to clinically...
- Patients taking strong CYP3A4 inducers such as rifampin and rifabutin in the 7 days prior to randomization or have the need for ongoing treatment...
- Patients taking strong CYP3A4 inhibitors such as clarithromycin in the 7 days prior to randomization or the need for ongoing treatment with...
- Patients taking clofazimine or bedaquiline AND who also have congestive heart failure, significant ventricular arrhythmia, uncorrected hypokalemia...
See the full eligibility criteria
- 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.
- NTM infection meeting current Pulmonary NTM guidelines from the American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) for systemic (IV) aminoglycoside therapy.
- Anticipated duration of IV amikacin treatment of at least 30 days at time of study entry.
- Statement of ability to take oral medication and adhere to the daily dosing regimen.
- For females of reproductive potential: If they are of childbearing potential, they must agree in writing to practice an effective double barrier method of contraception from the signing of the informed consent form...
- For males of reproductive potential: Agree to practice effective barrier contraception from the signing of the informed consent form until 3 months (one spermatogenesis cycle) following the last dose of study drug or...
- 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...
- Patients taking strong CYP3A4 inhibitors such as clarithromycin in the 7 days prior to randomization or the need for ongoing treatment with concomitant oral or intravenous therapy with strong CYP3A4 inhibitors during...
- Patients taking clofazimine or bedaquiline AND who also have congestive heart failure, significant ventricular arrhythmia, uncorrected hypokalemia, or ECG (single at Screening, mean of triplicate prior to randomization)...
- Patients with amikacin exposure within the 6 months prior to randomization.
- Patients with known amikacin resistance (MIC \>64)
- Progressive liver disease (Child-Pugh B or C) which would affect or invalidate interpretation of change from the baseline liver function tests over the course of the study.
- Signs of disturbed integrity of the tympanic membrane, determined by otoscopy or tympanometry, including chronic perforation or middle ear or ear canal inflammation or effusion.
- History of congenital hearing loss, otological surgery (excluding myringotomy tubes or simple tympanoplasty healed and currently intact), sudden hearing loss, or Meniere's disease.
- Bilateral profound hearing loss (\>90 Decibels [dB] HL) at all test frequencies.
- Conductive hearing loss evidenced by average air-bone-gaps \>15 dB HL for 0.25-4.0 kilohertz (kHz)
- History of active malignancy, either untreated or under active treatment.
- History of risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Venous access not adequate for performance of study procedures.
- Presence of any circumstance, condition, ECG or laboratory finding that, based on investigator judgment, would interfere with study procedures or assessments or present to the patient an unreasonable risk from...
- Current or anticipated use of excluded concomitant medications as specified in Section 6.5.
- Pregnant or lactating.
- Female of childbearing potential who does not have a negative serum pregnancy test and does not agree in writing to using a double barrier method of contraception.
- Female relying on menopausal status for contraception who does not have Follicle-Stimulating Hormone (FSH) level consistent with that condition and who does not agree in writing to using a double barrier method of...
- Currently under correctional supervision (imprisoned, on probation or parole).
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Denver, Colorado, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Manhasset, New York, United States
- Portland, Oregon, United States
- Charleston, South Carolina, United States
- Tyler, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Denver, Colorado, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; Manhasset, New York, United States; Portland, Oregon, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.