Phase 2 Tuberculosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to give their own informed consent by signing and dating the consent form, without needing a legal representative to do so on their behalf.
• People who are willing and able to follow the study procedures and attend all required visits for the full duration of the trial.
• People aged between 18 and 79 years old.
• People who have a non-tuberculous mycobacterial (NTM) lung infection that meets the standard medical guidelines (set by two major US medical societies) for treatment with intravenous (IV) amikacin, a type of antibiotic given through a drip.
• People whose doctors expect they will need IV amikacin treatment for at least 30 days when they enter the study.
• People who are able to swallow and regularly take oral (by mouth) medication each day.
• Women who could become pregnant must agree in writing to use two forms of barrier contraception, or to practise complete abstinence, from the time of signing the consent form until one month after stopping the study drug.
• Men who could father a child must agree in writing to use effective barrier contraception, or to practise complete abstinence, from signing the consent form until three months after the last dose of the study drug.

Who may not be able to join:

• People who have received a systemic aminoglycoside antibiotic (a certain class of antibiotic) within the six months before the planned first dose.
• People whose heart tracing (ECG) at screening shows a QTcF interval of 450 milliseconds or more (a measurement related to the heart's electrical activity) (confirm with trial site).
• People whose ECG shows abnormalities that, in the investigator's judgement, could increase the risk of a serious heart rhythm problem.
• People who have taken strong CYP3A4 inducers — such as rifampin or rifabutin (certain antibiotics) — within the seven days before entering the trial, or who would need to continue taking these medications during the study.
• People who have taken strong CYP3A4 inhibitors — such as clarithromycin (a certain antibiotic) — within the seven days before entering the trial, or who would need to continue taking these medications during the study.
• People taking clofazimine or bedaquiline (certain antibiotics) who also have heart failure, significant heart rhythm problems, low potassium levels, or an ECG showing specific abnormalities in heart rate or electrical conduction.
• People who have had any exposure to amikacin in the six months before entering the trial.
• People whose infection is known to be resistant to amikacin.
• People with serious progressive liver disease (classified as Child-Pugh B or C) that would affect interpretation of liver test results during the study.
• People with signs of a damaged or perforated eardrum, or inflammation or fluid in the middle ear or ear canal, as detected by ear examination.
• People with a history of hearing loss present from birth, certain ear surgeries, sudden hearing loss, or a condition called Menière's disease.
• People who have profound hearing loss in both ears across all tested sound frequencies.
• People with a specific type of hearing loss caused by a problem conducting sound through the ear (confirmed by hearing tests).
• People with an active cancer diagnosis that is either untreated or currently being treated.
• People with a history of risk factors for a serious heart rhythm condition called Torsades de Pointes, such as heart failure, low potassium, or a family history of Long QT Syndrome.
• People whose veins are not suitable for the blood draws and IV procedures required by the study.
• People who have any condition, test result, or circumstance that, in the investigator's judgement, could interfere with the study or pose an unreasonable risk to the person.
• People who are currently taking, or expected to take, any medications that are specifically excluded by the study protocol (confirm with trial site).
• People who are currently pregnant or breastfeeding.
• Women of childbearing potential who do not have a negative blood pregnancy test or who do not agree in writing to use two forms of barrier contraception.
• Women relying on menopause for contraception whose hormone levels do not confirm menopausal status, and who do not agree in writing to use two forms of barrier contraception.
• People who are currently in prison, on probation, or on parole.

Important: Always verify eligibility with the trial site directly before applying.