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Comparison of 6 months Isoniazid v/s 3 months Isoniazid - Rifampicin Therapy for Prevention of Tuberculosis in Children Suffering from Latent Tuberculosis Infection

Comparison of 6 months Isoniazid v/s 3 months Isoniazid - Rifampicin Therapy for Prevention of Tuberculosis in Children Suffering from Latent Tuberculosis Infection - An Open Label Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040539
Enrollment
32
Registered
2022-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: A150- Tuberculosis of lung Health Condition 2: A150- Tuberculosis of lung

Interventions

Intervention1: one group will receive 3 months daily Isoniazid and Rifampicin tablets (H-dose @ 10 mg/kg/day1, max 300 mg
R- 15 mg/kg/day1, max 600 mg) : (isoniazid-dose @ 10 mg/kg/day1, max 300 mg
Rifampicin- 15 mg/kg/day1, max 600 mg) Control Intervention1: One group will receive Isoniazid monotherapy for 6 months daily- dose @ 10 mg/kg/day1, max 300 mg.: rifampicin - dose @ 10 mg/kg/day1, ma

Sponsors

DR SHIVANGI SINHAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: children (6-14years)with LTBI living with sputum smear positive adult TB patients undergoing DOTS

Exclusion criteria

Exclusion criteria: children in contact with adults having multidrug resistant TB (MDR-TB) or Extensively drug resistanT TB(XDR-TB).

Design outcomes

Primary

MeasureTime frame
The proportion of children with LTBI developing Tuberculosis at 9 months after receiving treatment with 3 months HR v/s 6 months INH will be calculated and compared. Timepoint: 2 years

Secondary

MeasureTime frame
both groups will be compared in terms of adverse effectsTimepoint: 2 years

Countries

India

Contacts

Public ContactDR GEETIKA SRIVASTAVA

ERAS LUCKNOW MEDICAL COLLEGE

GEETIKASRI@GMAIL.COM9721066555

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026