CTRI/2008/091/000024
Recruiting
Phase 3
RANDOMISED CLINICAL TRIAL TO STUDY THE EFFICACY AND TOLERABILITY OF 3- AND 4-MONTH REGIMENS CONTAINING MOXIFLOXACIN IN THE TREATMENT OF PATIENTS WITH SPUTUM SMEAR AND CULTURE POSITIVE PULMONARY TUBERCULOSIS
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Pulmonary Tuberculosis
- Sponsor
- Indian Council of Medical Research
- Enrollment
- 1650
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a. Age 18 years to 60 years
- •b. Residing in or around Chennai or Madurai
- •c. No previous anti\-TB treatment
- •d. At least two sputum smears should be positive for tubercle bacilli by fluorescent microscopy at enrollment
- •e. Willing to attend the treatment centre for supervised treatment
- •f. Willing for home visits by the staff of the center.
- •g. Willing to give written informed consent.
Exclusion Criteria
- •a. Body weight less than 30 kg
- •b. Hepatic or renal disease as evidenced by clinical or biochemical abnormalities
- •c. Diabetes mellitus
- •d. History of seizure or loss of consciousness
- •e. Psychiatric illness
- •f. Abnormal electrocardiogram or anti\-arrhythmic medication
- •g. Those in a moribund state
- •h. Sero\-positive for HIV antibodies
- •i. Pregnancy or lactation
- •j. Visual disorders other than refractory error
Outcomes
Primary Outcomes
Not specified
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