Health Condition 1: null- New sputum positive pulmonary TB
Conditions
Interventions
Intervention1: Regimen 1:
2MHRZ thrice weekly/2 MHR thrice-weekly
Regimen 2:
2 GHRZ thrice weekly/ 2 GHR thrice weekly
: Regimen 1:
2 MHRZ thrice weekly/ 2 MHR thrice weekly: moxifloxacin, isoniazid,
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years and above residing in or around Chennai or Madurai will be eligible for enrollment to the study. They should not have anti-TB treatment in the past or should have had less than one month of treatment (but less than one week in the preceding one month before enrollment in the study). They should have sputum culture-positive pulmonary tuberculosis (at least two cultures should be positive). Patients will be enrolled to the study when two sputum smears are positive and will be retained for analysis only if two cultures are positive. They should consent to attend the treatment centre for supervised treatment for 6 months and for home visits by the staff of the center. They should give written informed consent.
Exclusion criteria
Exclusion criteria: body weight less than 30 kg hepatic or renal disease as evidenced by clinical or biochemical abnormalities diabetes mellitus a history of seizures psychiatric illness an abnormal electrocardiogram or those on anti-arrhythmic medication Those in a moribund state Those sero-positive for HIV antibodies Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TB Recurrence rateTimepoint: Up to 24 months post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Sputum culture conversion at 2 months b) Status at end of treatment c) Treatment related adverse reactionTimepoint: a) Sputum culture conversion - 2 months b) status at end of treament - 4 or 6 months c) Drug related adverse reactions - during treatment | — |
Countries
India
Contacts
Public ContactMSJawahar
National Institute for Research in TB
Outcome results
None listed