Thrice weekly 4- months moxifloxacin or gatifloxacin regimens for pulmonary TB
- Conditions
- Health Condition 1: null- New sputum positive pulmonary TB
- Registration Number
- CTRI/2012/10/003060
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 1200
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TB Recurrence rateTimepoint: Up to 24 months post-treatment
- Secondary Outcome Measures
Name Time Method a) Sputum culture conversion at 2 months <br/ ><br>b) Status at end of treatment <br/ ><br>c) Treatment related adverse reactionTimepoint: a) Sputum culture conversion - 2 months <br/ ><br>b) status at end of treament - 4 or 6 months <br/ ><br>c) Drug related adverse reactions - during treatment