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A clinical trial to study the effects of moxifloxacin with regular anti-tuberculosis drugs in Tuberculosis patients

Not Applicable
Conditions
Health Condition 1: null- Newly diagnosed Tuberculosis Patients and relapse TB cases with no resistance
Registration Number
CTRI/2016/03/006713
Lead Sponsor
Vijey Aanandhi M
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
131
Inclusion Criteria

1.Patients who are newly diagnosed with pulmonary tuberculosis

2.Patients with relapse of tuberculosis

Exclusion Criteria

1.Patients with known resistance for at-least one of the four first line drugs.

2.Patients with Extra-pulmonary tuberculosis

3.Pregnant and nursing women

4.Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with fluoroquinolones.

5.Patients already receiving anti-retroviral therapy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Moxifloxacin arm is expected to show rapid sputum negativity.Timepoint: At the end of 2 months(intensive phase) and at the end of 6 months ( continuation phase)
Secondary Outcome Measures
NameTimeMethod
Measurement of Adverse drug eventsTimepoint: Every week of follow up
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