An evaluation of two eight-month regimens of chemotherapy for the treatment of newly diagnosed pulmonary tuberculosis

Completed

Conditions: Smear-positive pulmonary tuberculosis
Infections and Infestations
Respiratory tuberculosis, bacteriologically and histologically confirmed

Registration Number: ISRCTN19832141

Lead Sponsor: International Union Against Tuberculosis and Lung Disease (France)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1500

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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