Peer-reviewed article
Safety and Side Effects of Rifampin versus Isoniazid in Children
Thierno Diallo, Mênonli Adjobimey, Rovina Ruslami, Anete Trajman, Oumou Bah Sow et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study compared two drug treatments for children with latent tuberculosis infection: 4 months of rifampin versus the standard 9 months of isoniazid. The trial involved 829 children under 18 years old across multiple countries. Rifampin showed better completion rates and similar safety, with no active tuberculosis cases developing in the rifampin group compared to 2 cases in the isoniazid group.
Key points
- 85.3% of children in the rifampin group completed treatment compared to 76.4% in the isoniazid group (13.4 percentage point difference)
- Fewer than 5% of children in both groups experienced grade 1 or 2 adverse events possibly related to the trial drugs
- Two cases of active tuberculosis developed in the isoniazid group (one with isoniazid resistance) versus zero cases in the rifampin group during follow-up
- Rifampin treatment took 4 months versus 9 months for isoniazid, reducing treatment duration
- Safety profiles were similar between the two treatment regimens
Limitations
This was an open-label trial, so participants and staff knew which treatment was being given, which could influence reporting of side effects and adherence. The study measured latent tuberculosis infection treatment outcomes over a defined follow-up period, but longer-term durability of protection cannot be determined from this data.
Abstract
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 .).
Findings the Hub has extracted
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