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 have been diagnosed with tuberculous meningitis (a type of brain infection caused by TB) — whether that diagnosis is confirmed, probable, or possible — and who are already receiving or committed to receiving a full course of standard TB treatment as part of their regular medical care
• People who have been tested for HIV within the past 30 days and the result was negative, OR people who have a documented HIV-positive diagnosis confirmed through recognised medical testing
• People whose stage of illness has been recorded by their medical team within 3 days before joining the study, using a standard TB meningitis grading scale
• People whose recent blood test results (taken within 3 days before joining) fall within acceptable ranges for kidney function, red blood cell levels, white blood cell levels, platelet count, and liver function
• People who are able to become pregnant and have had a pregnancy test (positive or negative) within 21 days before joining the study — those with a negative result must agree to use at least one accepted form of contraception, or avoid sexual activity that could lead to pregnancy, during treatment and for 30 days after finishing it
• People who are pregnant and have a positive pregnancy test result will be asked to sign a specific consent form designed for pregnant participants
• People who cannot become pregnant, or whose partner has a documented medical condition meaning they cannot father children, are not required to use contraception (confirm with trial site)
• People — or their parent or legal representative, in the case of adolescents or those unable to consent for themselves — who are willing and able to give informed consent to take part
• People who, in the opinion of the trial doctor, are able to follow the requirements of the study

Who may not be able to join:

• People who have already taken more than 14 days' worth of standard first-line TB medications (such as isoniazid, rifampicin, ethambutol, or pyrazinamide) in the 90 days before joining the study
• People who are known to have a strain of TB that is resistant to one or more standard TB medications
• People who have a known allergy or sensitivity to any of the study medications or their ingredients
• People who, within 21 days before joining, were assessed for nerve-related symptoms and showed a certain level of nerve damage in their feet or legs, as measured by a standard screening tool (confirm with trial site for exact threshold)
• People who are taking, or have taken within the past 21 days, a type of antidepressant called a monoamine oxidase inhibitor (MAOI) or a selective serotonin reuptake inhibitor (SSRI), or any other medication known to interact significantly with the study drugs
• People with HIV who have never started HIV treatment, or who are not regularly taking it, and who plan to begin or restart HIV treatment during the screening period or within the first 4 weeks of TB treatment
• People with HIV who are currently taking certain types of HIV medications (such as protease inhibitors or nevirapine) and for whom switching to an alternative HIV medication before starting the study is not medically possible
• People for whom a lumbar puncture (a procedure to collect fluid from around the spine) is considered unsafe by their treating doctor — for example, due to certain brain conditions
• People whose recent spinal fluid test results (taken within 21 days before joining) show signs of a brain or nervous system infection caused by something other than TB — for example, fungal or bacterial meningitis

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