Phase 2 Tuberculosis Trial, Recruiting

Written by an AI model from the 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 aged 18 or older at the time of screening (or above the legal age of consent in the country where the trial is taking place, if that age is higher than 18)
• People who show signs of active tuberculosis (TB), either through symptoms that suggest TB in the lungs, or through chest X-ray results consistent with active TB taken at screening or within 7 days before screening
• People who have provided a sputum (mucus coughed up from the lungs) sample at screening that tested at a 'medium' or 'high' level on a specific TB test called Xpert MTB/RIF Ultra, and did not show resistance to the TB drug rifampicin
• People whose body weight is between 30 and 100 kg, and whose body mass index (BMI) is between 15 and 40 kg/m²
• People who are willing to attend all required study visits and follow all study procedures
• People who live at a fixed address that is easy to visit and within a practical distance of the trial site, and who are likely to remain living there for the full duration of the trial
• People who have given written consent to participate in the trial

Who may not be able to join:

• People who have taken more than one daily dose of any TB-fighting medication in the 14 days before being assigned to a treatment group (this applies to certain phases of the trial and covers medications such as isoniazid, rifampicin, pyrazinamide, ethambutol, linezolid, moxifloxacin, levofloxacin, or amikacin)
• People who are known to have a form of TB that does not respond to the drug isoniazid
• People who are known or suspected to have TB that has spread outside the chest area, TB spread throughout the body (miliary TB), or widely spread TB — though a small fluid collection around the lung or nearby swollen lymph nodes may not automatically exclude someone (confirm with trial site)
• People whose TB is considered severe, such as those with breathing failure or complications that would likely require a hospital stay, in the opinion of the treating doctor
• People who are in very poor general health (as assessed using a standard health scoring tool called the Karnofsky scale) or where the doctor believes any delay in starting treatment would not be safe
• People currently being treated for an active cancer with chemotherapy, radiation, or palliative care
• People with a history of heart attack, coronary heart disease, or heart failure; a condition causing an abnormally long heart rhythm (long QT syndrome); irregular heartbeat of clinical concern; high blood pressure in the lungs; any known heart problem present from birth; a family history of long QT syndrome or unexplained or heart-related sudden death; or uncontrolled high blood pressure that has not been corrected before joining the trial
• People with vitiligo (a skin condition that causes patches of skin to lose their colour)
• People with a history of seizures (fits)
• People who currently have tendon pain or inflammation (tendinitis), or who have a history of tendon problems caused by a group of antibiotics called fluoroquinolones
• People with a history of a blood vessel aneurysm (a bulge in an artery wall)
• People with nerve damage in the hands or feet (peripheral neuropathy) that causes more than minor interference with everyday activities
• People whose current use of alcohol or illegal drugs would, in the opinion of the investigator, put them or research staff at risk, or make it difficult to follow study procedures reliably
• People who currently use or have recently used amphetamines or methamphetamines, either as reported or shown by a drug test if one is performed
• People with any other significant medical or social condition — such as a psychiatric illness, long-term digestive disease, a metabolic condition, or other heart or circulatory problems not already listed — that the investigator believes could affect the person's safety, the reliability of the study results, or the ability to attend visits and follow study requirements
• People who are currently pregnant or breastfeeding
• Women who are able to become pregnant and are unwilling or unable to use effective contraception throughout the treatment period and for at least 14 days after the last dose of study medication, or who are unwilling to commit to not donating eggs for reproduction during this period (confirm with trial site for definitions of childbearing potential and accepted contraception methods)
• Men who are unwilling to use a condom during any activity that could pass ejaculate to another person throughout the study period and for at least 90 days after the last dose of study medication, or who are unwilling to commit to not donating fresh semen during this time
• People who are known to be allergic to any of the study medications
• People who are taking another medication that is known or expected to interact with any of the study drugs — though this may not be an exclusion if the other medication can be safely stopped or swapped for a non-interacting alternative, and the investigator is satisfied there is no remaining risk to the person
• People who are taking a medication known to affect the heart's electrical rhythm in a specific way (QTc prolongation) — though this may not be an exclusion if the medication can be stopped or replaced in time for its effect to wear off before study medication begins
• People who have taken immune-suppressing medications in the two weeks before screening (short courses of steroid tablets lasting fewer than 5 days that were stopped at or before screening are generally not excluded; low-dose topical or inhaled steroids that do not have a body-wide suppressing effect are also generally not excluded — confirm with trial site)
• People who have taken part in another clinical trial involving an experimental treatment within 8 weeks before the first day of dosing in this trial
• People whose heart tracing (ECG) at screening or baseline shows a specific electrical measurement that is too long (above 450ms for men or 460ms for women using a standard calculation method), or any other significant heart rhythm or circulation abnormality
• People whose blood test results at screening fall outside acceptable ranges, including: low red blood cell levels (haemoglobin below 9 g/dL); low platelet count; low levels of a type of white blood cell called neutrophils; reduced kidney function below a certain level; liver enzyme levels (ALT or AST) more than 3 times the upper normal limit; elevated bilirubin more than 1.5 times the upper normal limit; or low levels of potassium, magnesium, or calcium in the blood — though low mineral levels may not be an exclusion if they are corrected before joining
• People who test positive for Hepatitis B surface antigen (either already known or found at screening)
• People who test positive for HIV antibodies (either already known or found at screening) (confirm with trial site)
• People with a known Hepatitis C virus infection, unless a PCR test has confirmed the virus is no longer active (confirm with trial site)

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