Tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
Test arm: 4 FDC formulation (ethambutol (275 mg)/ rifampicin (150 mg)/ isoniazid (75 mg)/ pyrazinamide (400 mg) followed by 2 FDC formulation (rifampicin (150 mg)/ isoniazid (75 mg))
Control arm: Loo
Sponsors
UNDP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with newly diagnosed pulmonary tuberculosis (with or without pleural effusion) will be admitted to the study provided they fulfill the following criteria: 1. Two sputum specimens positive for tubercle bacilli on direct smear microscopy. A patient is considered smear positive if: 1.1. 2 out of 3 consecutive sputum smears are read as positive, or 1.2. 2 out of 5 are read as positive in the event that only one of the first three smear is positive, in which case the patient will be asked for two more specimens: one morning and one spot. 2. No history of previous anti-tuberculosis chemotherapy, or antiretroviral therapy 3. Aged 18 years and over 4. A firm home address and intent to remain there during the entire treatment and follow up period 5. Informed consent to participate in the study 6. Weight between 40.00 kg and 70.00 kg inclusive 7. Acceptance of human immunodeficiency virus (HIV) counselling and testing 8. CD4 more than or equal to 220 cells/microlitre blood if the patient is HIV positive in Nigeria 9. CD4 > 350cells/microlitre blood if the patient is HIV positive In Ethiopia
Exclusion criteria
Exclusion criteria: 1. Positive urinary pregnancy test or obviously pregnant on physical examination 2. Additional extrapulmonary TB (e.g. bone, meningeal, peritoneal or miliary) 3. Contraindications to any medications in the study regimens (e.g. documented allergy, optic neuritis, blurred vision, red-green colour blindness and poor visual acuity any active hepatic diseases 4. Evidence (laboratory and/or clinical history) of pre-existing non-tuberculous disease likely to affect the response to, or assessment of, treatment: 4.1. Diabetes mellitus 4.2. Liver impairment 4.3. Renal impairment 4.4. Peripheral neuropathy 4.5. Terminal illness such as malignancy 5. Requirement for hospitalisation for any reason other than directly observed treatment (DOT) 6. Concomitant immunosuppressive treatment during the whole study period 7. Psychiatric illness, alcohol or drug abuse likely to lead to uncooperative behaviour 8. Patients on antiretroviral treatment during TB treatment period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rates at end of treatment (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Early response rates: proportion of patients with negative culture results at 8 weeks after initiation of therapy 2. Proportion of patients with relapses during the 72 weeks follow up period after the end of treatment. A relapse is a patient previously treated for tuberculosis who has met the case definition of cure (as defined above) and been declared cured by a physician and who has now been diagnosed with bacteriologically positive (two positive smears and culture positive) tuberculosis. If there is discordance between smear and culture results, a clinical decision will be made regarding further management: 2.1. Smear positive, culture negative, and 2.2. Smear negative and culture positive 3. Cure rates in HIV positive TB patients 4. Proportion of patients with clinical deterioration of pulmonary tuberculosis with the need for hospitalisation 5. Proportion of patients with serious adverse events any time during chemotherapy 6. Proportion of patients with any adverse events during chemotherapy 7. Proportion of patients completing treatment (defined as patients who achieved a total of 54 out of 56 doses in the first eight weeks of treatment and 107 out of 112 doses at a daily rate during the subsequent 16 weeks of treatment) within each group. (96% doses taken considered as completed in intensive and maintenance phases). 8. Proportion of patients who developed multi-drug-resitant (MDR)-TB | — |
Countries
Ethiopia, Nigeria
Outcome results
None listed