MedPath

management of patients who do not respond to initial anti-tuberculosis treatment

Phase 3
Conditions
Health Condition 1: null- Multidrug Resistant Tuberculosis
Registration Number
CTRI/2014/01/004294
Lead Sponsor
nited State Agency for International Development
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Other (Terminated)
Sex
Not specified
Target Recruitment
150
Inclusion Criteria

A patient whose TB is due to bacilli resistant to at least isoniazid and rifampicin with or without resistance to other drugs will be eligible for the study.

At least one sputum smear examined within 10 days of starting treatment should be positive for AFB.

Exclusion Criteria

Patients under 15 years of age

Pregnant women

Having a current major psychiatric illness

Having had over one month treatment with any second line anti-TB drugs.

HIV positive cases

A patient with concurrent illness such as epilepsy, renal or hepatic problems.

Too sick for ambulatory treatment

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
sputum smear and culture conversion at 3 months and 6 months of treatmentTimepoint: sputum smear and culture conversion at 3 months and 6 months of treatment
Secondary Outcome Measures
NameTimeMethod
Favourable bacteriological response at the end of treatment. <br/ ><br>Adverse reactions to anti-TB drugs <br/ ><br>Timepoint: at 24 months of treatment
© Copyright 2025. All Rights Reserved by MedPath