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

A Randomized Controlled Trial on the Safety and Efficacy of Moxifloxacin with Conventional Antituberculosis Therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/03/006713
Enrollment
131
Registered
2016-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Newly diagnosed Tuberculosis Patients and relapse TB cases with no resistance

Interventions

Control Intervention1: MOXIFLOXACIN: 400mg OD MOXIFLOXACIN P/O

Sponsors

Vijey Aanandhi M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who are newly diagnosed with pulmonary tuberculosis 2.Patients with relapse of tuberculosis

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Measurement of Adverse drug eventsTimepoint: Every week of follow up—

Countries

India

Contacts

Public ContactPraveen D

vels university

praveennandan.1993@gmail.com9940510419

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026