To compare number of healthy household contacts aged less than 5 years developing Tuberculosis disease after receiving treatment with 3 months isoniazid and rifampicin versus 6 months isoniazid

Comparison of 6 months isoniazid versus 3 months isoniazid plus rifampicin for tuberculosis preventive therapy in children less than 5 years- an open label randomised control trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052273

Enrollment

130

Registered

2023-05-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

None listed

Interventions

Intervention1: Clinical Trial: Group A-receiving isoniazid for 6 months. Group B-receiving isoniazid plus rifampicin for 3 months. Intervention2: Healthy contacts receiving Isoniazid: Healthy contacts

Eligibility

Inclusion criteria

Inclusion criteria: ALL children less than 5 years of age who are household contacts that is living with bacteriologically confirmed pulmonary tuberculosis patients after ruling out tuberculosis disease in them.

Exclusion criteria

Exclusion criteria: Children in contact with adults having multidrug resistant tuberculosis or extensively drug resistant tuberculosis.

Design outcomes

Primary

Measure	Time frame
Finding the proportion of children less than 5 years of age who are household contacts of pulmonary Tuberculosis patients, developing tuberculosis after receiving treatment with 3 months isoniazid and rifampicin versus 6 months isoniazid. Timepoint: 2 years	—

Secondary

Measure	Time frame
Finding the Non adherence, Adverse drug events and Completion rate in the proportion of children less than 5 years of age who are household contacts of Tuberculosis patient, after receiving treatment for 6 month isoniazid versus 3 month isoniazid and rifampicinTimepoint: 2 years	—

Countries

India

Contacts

Public ContactAreej Bano

Eras Lucknow Medical College and Hospital

geetikasri@gmail.com

Outcome results