Skip to content

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

Management of patients who fail to Category II regimen of the TB control program

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004294
Enrollment
150
Registered
2014-01-07
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- Multidrug Resistant Tuberculosis

Interventions

Intervention1: Injection kanamycin (intramuscular) intermittent: Intermittent Kanamycin is given as intramuscular injection thrice weekly along with oral anti-TB drugs for 6 months Control Interventio

Sponsors

United State Agency for International Development
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Favourable bacteriological response at the end of treatment. Adverse reactions to anti-TB drugs Timepoint: at 24 months of treatment

Countries

India

Contacts

Public ContactDr Soumya Swaminathan

National Institute for Research in Tuberculosis

doctorsoumya@yahoo.com044-28369600

Outcome results

None listed

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