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Safety and Side Effects of Rifampin versus Isoniazid in Children
Thierno Diallo1, Menonli Adjobimey1, Rovina Ruslami1
1From Service de Pneumophtisiologie, Hôpital National Ignace Deen, Université Gamal Abdel Nasser de Conakry, Conakry, Guinea (T.D., O.S.); the Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill University Health Centre Research Institute (T.D., A.T., D.Z., C.V., F.F., K.H., P.Z.L., K.S., A.B., D.M.), the Departments of Medicine and of Epidemiology, Biostatistics, and Occupational Health (A.B.), and Montreal Children's Hospital (D.Z.), McGill University, Montreal, the TB Program Evaluation and Research Unit, University of Alberta, Edmonton (R.L.), and the British Columbia Centre for Disease Control and University of British Columbia, Vancouver (K.E.) - all in Canada; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin (M.A., M.G.); Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia (R.R., D.A.W., L.A.); the Social Medicine Institute, Rio de Janeiro State University, Rio de Janeiro (A.T.); Komfo Anokye Teaching Hospital, Kumasi, Ghana (J.O.B.); the University of New South Wales, Sydney (G.B.M.); and the Centre for International Health, University of Otago, Dunedin, New Zealand (P.C.H.).
Insights
Four months of rifampin treatment for latent tuberculosis infection in children showed improved adherence compared to nine months of isoniazid, with similar safety and efficacy. This offers a potentially more effective treatment option for pediatric tuberculosis.
Area of Science:
- Pediatric infectious diseases
- Mycobacterial infections
- Clinical pharmacology
Background:
- Latent Mycobacterium tuberculosis infection in children poses a risk for severe disease.
- Current 9-month isoniazid treatment is limited by poor adherence and toxicity.
- Adult studies suggest 4-month rifampin is a safer alternative with higher completion rates.
Purpose of the Study:
- To compare the safety, adherence, and efficacy of 4-month rifampin versus 9-month isoniazid for latent tuberculosis infection in children.
- To evaluate adverse events and progression to active tuberculosis in pediatric patients.
Main Methods:
- Multicenter, open-label trial randomizing 844 children (<18 years) to 4-month rifampin or 9-month isoniazid.
- Primary outcome: drug discontinuation due to adverse events (grade 1-5).
- Secondary outcomes: treatment adherence, side effects, and efficacy (progression to active TB).
Main Results:
- 85.3% of children in the rifampin group completed therapy versus 76.4% in the isoniazid group (13.4% higher completion rate).
- No significant differences in adverse events between groups; <5% possibly related to trial drugs.
- No active tuberculosis cases in the rifampin group vs. 2 in the isoniazid group during follow-up.
Conclusions:
- Four-month rifampin treatment for pediatric latent tuberculosis infection demonstrates superior adherence compared to 9-month isoniazid.
- Both regimens showed comparable safety and efficacy profiles in children.
- Rifampin offers a promising alternative for improving treatment completion in pediatric TB management.
Background:
The treatment of latent infection with Mycobacterium tuberculosis is important in children because of their vulnerability to life-threatening forms of tuberculosis disease. The current standard treatment - 9 months of isoniazid - has been associated with poor adherence and toxic effects, which have hampered the effectiveness of the drug. In adults, treatment with 4 months of rifampin has been shown to be safer and to have higher completion rates than 9 months of isoniazid.
Methods:
In this multicenter, open-label trial, we randomly assigned 844 children (<18 years of age) with latent M. tuberculosis infection to receive either 4 months of rifampin or 9 months of isoniazid. The primary outcome was adverse events of grade 1 to 5 that resulted in the permanent discontinuation of a trial drug. Secondary outcomes were treatment adherence, side-effect profile, and efficacy. Independent review panels whose members were unaware of trial-group assignments adjudicated all adverse events and progression to active tuberculosis.
Results:
Of the children who underwent randomization, 829 were eligible for inclusion in the modified intention-to-treat analysis. A total of 360 of 422 children (85.3%) in the rifampin group completed per-protocol therapy, as compared with 311 of 407 (76.4%) in the isoniazid group (adjusted difference in the rates of treatment completion, 13.4 percentage points; 95% confidence interval [CI], 7.5 to 19.3). There were no significant between-group differences in the rates of adverse events, with fewer than 5% of the children in the combined groups with grade 1 or 2 adverse events that were deemed to be possibly related to a trial drug. Active tuberculosis, including 1 case with resistance to isoniazid, was diagnosed in 2 children in the isoniazid group during 542 person-years of follow-up, as compared with no cases in the rifampin group during 562 person-years (rate difference, -0.37 cases per 100 person-years; 95% CI, -0.88 to 0.14).
Conclusions:
Among children under the age of 18 years, treatment with 4 months of rifampin had similar rates of safety and efficacy but a better rate of adherence than 9 months of treatment with isoniazid. (Funded by the Canadian Institutes of Health Research and Conselho Nacional de Pesquisa; ClinicalTrials.gov number, NCT00170209 .).
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