None listed
Conditions
Interventions
Patients enrolled in the trial will be randomly allocated to receive one of the following three chemotherapy treatment regimens:
1. Control regimen (R10): The standard regimen of isoniazid, pyrazin
Sponsors
St Georges University of London,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria 1. Patients with: a) Newly diagnosed, smear microscopy positive, pulmonary tuberculosis, rifampicin susceptible MTBC confirmed by Xpert MTB/RIF OR b) Smear microscopy negative, suspected pulmonary tuberculosis, confirmed by Xpert MTB/RIF as sputum MTBC positive and rifampicin susceptible 2. No more than one week of previous treatment for tuberculosis, for either active TB or treatment of confirmed or presumed latent TB infection. 3. Patients ≥ 18 years old 4. Consent to participation in the trial and to HIV testing 5. Provide informed consent. 6. Patient has a stable home address within easy reach of the treatment facility and likely to remain there for the entire treatment and follow-up period. 7. Women who are pre-menopausal or of a child-bearing age must be using a barrier form of contraception (condoms, diaphragms, cervical caps, or contraceptive sponges), be surgically sterilised or have an intrauterine coil device (IUCD) in place for the duration of the treatment phase, alternatively they should agree to abstain from sexual activity during the treatment phase.
Exclusion criteria
Exclusion criteria: 1. Patients with rifampicin resistance identified by Xpert MTB/RIF or by direct susceptibility testing (late exclusions). 2. Patient is in a moribund phase. 3. Has TB meningitis or extra-pulmonary TB. 4. Is female and known to be pregnant, or breast feeding. 5. Is suffering from a condition likely to lead to uncooperative behaviour such as psychiatric illness or alcoholism. 6. Has a history of seizures 7. Has contraindications to any medications in the study regimens 8. Is HIV positive according to local testing algorithm 9. Has a blood disorder (including grade 4 or above thrombocytopenia) 10. Haemoglobin 5 times the upper limit of normal (ULN) for that laboratory 14. Raised Bilirubin (grade 4 or above) 15. Has kidney disease 16. Estimated Creatinine clearance of 48mmol/mol 19. Weight < 35kg 20. Patient is taking any of the excluded medications listed in the Summary of Product Characteristics (SmPC) for any trial drugs 21. Has other pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment as judged by the Principal Investigator.
Countries
Bolivia, Botswana, Peru, Uganda
Contacts
Public ContactEduardo Romulo Ticona
Tropical Levir S.A.C.
Outcome results
None listed