Evaluation of high dose rifampicin toxicity in pulmonary tuberculosis

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Newly diagnosed pulmonary tuberculosis
2. Two sputum specimens positive for tubercle bacilli on direct smear microscopy
3. No previous anti-tuberculosis chemotherapy
4. Aged 18 years and over
5. A firm home address that is readily accessible for visiting and be intending to remain there or within the recruitment area for the entire treatment period
6. Agree to participate in the study and to give a sample of blood for HIV testing
7. Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an interuterine contraceptive device (IUCD) in place for the duration of the treatment phase

Exclusion Criteria

1. Has any condition (except HIV infection) that may prove fatal during the study period
2. Has TB meningitis
3. Has pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g. insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis
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 contraindications to any medications in the study regimens
7. Requires anti-retro viral treatment (ART) at diagnosis
8. Haemoglobin <7g/l
9. Asparate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 5 times the upper limit of normal (ULN) for that laboratory
10. Creatinine clearance of < 30mls/min
Calculated as ((140-age) x weight x 1.23 x (0.85 if female))/Creat[micromol/l)
11. Has glucose in urine
12. Is HIV positive with a CD4 count of less than 350/mm3
13. Weight < 35kg

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of grade 3 or 4 adverse events at any time during chemotherapy

Secondary Outcome Measures

Name	Time	Method
1. Culture conversion at the end of 8 weeks of chemotherapy<br>2. Per protocol analysis of the primary outcome.<br>3. Any adverse event graded according to the modified Division of Aids (DAIDS) criteria<br>4. Rate of completion of chemotherapy according to the protocol<br>5. Number of observed doses of chemotherapy ingested