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:

• Adults aged 18 years or older but younger than 75 years old
• Women of childbearing age who are willing and able to use effective contraception (with a condom strongly recommended) for the full length of the study and for 6 months after treatment ends
• Men who are willing and able to use effective contraception for the full length of the study and for 3 months after treatment ends
• People who have a first-ever tuberculosis (TB) infection located in the lungs, confirmed by symptoms, chest X-ray or CT scan, a positive sputum test showing TB bacteria, and a genetic test confirming TB with no resistance to the antibiotic rifampicin, and with no signs of TB spread outside the chest
• People without standard government health coverage who have applied for state medical assistance (and the application is being processed)
• People who have read and signed the informed consent form agreeing to take part in the study

Who may not be able to join:

• People whose TB bacteria show resistance to any of the anti-TB drugs used in this trial, detected by a genetic test, as per 2015 public health guidelines
• People who have previously been treated for TB (though people with a documented genetic test showing no resistance to isoniazid and rifampicin may still be considered — confirm with trial site)
• People who have taken any of the antibiotics being tested in this trial for more than one month within the past two years
• People for whom there is a strong medical reason to avoid at least one of the drugs being studied (isoniazid, rifampicin, ethambutol, pyrazinamide, linezolid, or tedizolid)
• People whose TB is considered severe enough by the doctor in charge that starting standard treatment cannot safely be delayed by 7 days — for example, people who need oxygen support, have seriously weakened immune systems, have TB outside the lungs, or need intensive care
• People living with HIV who are taking certain HIV medications called protease inhibitors that cannot be changed, and which cannot be safely combined with rifampicin
• People currently receiving chemotherapy or radiation therapy for cancer
• People with severe liver disease (decompensated cirrhosis)
• People who are pregnant, trying to become pregnant, or currently breastfeeding
• Adults who are under legal guardianship, curatorship, or judicial protection
• People with significantly abnormal blood test results, including low red blood cells, very low white blood cells or platelets, poor kidney function, raised liver enzymes, or raised bilirubin levels (confirm specific values with trial site)
• People with abnormally high uric acid levels in the blood (hyperuricaemia)
• People with a condition called porphyria (a rare metabolic disorder)
• People with inflammation of the optic nerve (optic neuritis) or nerve damage in the hands or feet (peripheral neuropathy)
• People with a body mass index (BMI) of 16 or below (confirm with trial site)
• People currently taking part in another interventional research study
• People currently taking, or who have taken within the past two weeks, certain medications that interact dangerously with one of the study drugs (linezolid) — including a group of medicines called MAO inhibitors such as phenelzine, isocarboxacid, selegiline, and moclobemide
• People currently taking certain other medications that interact with the combination of TB drugs used in this trial, including (but not limited to): bictegravir, cobicistat, daclatasvir, dasabuvir, delamanid, grazoprevir/elbasvir, ritonavir-boosted protease inhibitors, isavuconazole, ledipasvir, lurasidone, midostaurin, ombitasvir/paritaprevir, praziquantel, rilpivirine, sofosbuvir, velpatasvir, voriconazole, or voxilaprevir
• People taking certain stomach-coating or antacid medications containing aluminium hydroxide or similar compounds that can affect how the study drugs are absorbed (confirm with trial site)

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