Comparison of 6 months isoniazid versus 3 months isoniazid - rifampicin therapy for prevention of tuberculosis in children suffering from tuberculosis infection - A randomized controlled trial

Background Tubercular infection is highly prevalent in our country and conversion to tuberculosis disease is a major concern. Under the National Strategic Plan, India is heading towards ending tuberculosis by 2025. The benefits of tuberculosis preventive therapy are being extended to the children aged ≥5 years, adolescents and adults who are household contacts of people with bacteriologically confirmed pulmonary tuberculosis who are found not to have active tuberculosis. Many types of tuberculosis preventive therapy are studied, the choice depends on availability and tolerability profile. Therefore, this study had an aim of comparing effectiveness of 6 months of Isoniazid (6H) with 3 months Isoniazid-Rifampicin (3HR) therapy in children suffering from tubercular infection. Method A randomized trial (CTRI No- CTRI/2022/02/040539), was carried out comparing two different regimes of tuberculosis preventive therapy. Children with age 6-14 years who were household contacts of bacteriologically confirmed tuberculosis patients and having tubercular infection were enrolled. After ruling out tuberculosis, they were randomized into two groups and started on either six month of isoniazid therapy or three months of isoniazid-rifampicin combination. They were followed up for a period of two years for development of tuberculosis, treatment adherence, treatment completion and adverse effects. Result There was no incidence of active tuberculosis in either of two groups till the last follow up. Treatment adherence was comparable in both the groups (p = 1). Treatment completion rate was significantly higher in Group 3HR (96.9%) as compared to that in Group 6H (p = 0.046). Loss to follow-up rate was 3.1% in 3HR as compared to 9.4% in 6H group (p = 0.613). No significant symptomatic adverse events or derangement in liver enzymes was observed in either the groups. Conclusion Three months of isoniazid-rifampicin therapy is an effective regime for tuberculosis preventive therapy in children age 6-14 years living in household contact of bacteriologically confirmed tuberculosis patients.