Smear-positive pulmonary tuberculosis Infections and Infestations Respiratory tuberculosis, bacteriologically and histologically confirmed
Conditions
Interventions
Participants from 8 sites with smear positive pulmonary tuberculosis who had never previously treated were randomly assigned from a table of random numbers to one of three treatment regimens:
1. Inte
Sponsors
International Union Against Tuberculosis and Lung Disease (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 15 to 65 years 2. Two sputum specimens positive for acid-fast bacilli on direct smear microscopy 3. No previous anti-tuberculosis chemotherapy for more than one month 4. A specific home address readily accessible for visiting in case of a failure to attend 5. Informed consent given and agreed to participate in the study and to give a sample of blood, urine or saliva for HIV testing
Exclusion criteria
Exclusion criteria: 1. So ill they were thought unlikely to survive the initial weeks of treatment 2. Presence of extra-pulmonary tuberculosis 3. Concomitant diseases likely to prejudice the response to, or assessment of, treatment such as 3.1. Diabetes 3.2. Liver disease 3.3. Nephritis 3.4. Blood disorders 3.5. Epilepsy 3.6. Peripheral neuritis 4. Known to be pregnant 5. Suffering from a psychiatric illness or alcoholism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with negative cultures at two months and the status of patients 12 months after completion of chemotherapy (i.e. at 18 or 20 months after start of chemotherapy depending on the regimen). The two-month culture result was chosen to compare the rate of sputum conversion of the three times weekly intensive phase with that of the daily intensive phase | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of failures at the end of chemotherapy (at 6 or 8 months after start of chemotherapy) and the proportion patients with adverse events requiring stopping of their chemotherapy or an interruption of treatment for 7 days or more | — |
Countries
Benin, China, Guinea, Mozambique, Nepal, Tanzania
Outcome results
None listed