ArticleIJTLD open2025
High-dose amikacin in the first week of all-oral rifampicin-resistant TB treatment is safe: a single-arm trial.
Article in IJTLD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Home-Based Monitoring of Treatment-Related Adverse Events during Drug-Resistant Tuberculosis Treatment, India, 2020-2024.Emerging infectious diseases · 2026Article
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Authors and funding
20 authors.
Funding
Abstract
backgroundEffective rifampicin-resistant TB (RR-TB) treatment should prevent resistance development. Bedaquiline is central to all-oral regimens, but it is threatened by rising resistance, possibly due to its delayed bactericidal effect. We evaluated the safety of strengthening the 1st week of all-oral RR-TB treatment with amikacin.
methodsIn a single-arm trial, 20 RR-TB patients received two intramuscular doses of amikacin (30 mg/kg) with lidocaine on the first and fourth day of treatment. The assumption was that none of the 20 patients would experience a grade 3-4 amikacin-related adverse event, corresponding to a primary hypothesis that less than 14% of patients have a grade 3-4 adverse event related to amikacin. Nephrotoxicity, ototoxicity, and pain post-injection were monitored. Early bactericidal effect and amikacin pharmacokinetics were measured.
resultsNone of the 20 patients experienced a grade 3-4 adverse event during the first 2 weeks of treatment (95% confidence interval: 0-0.139). No hearing loss of any grade was observed. Pain assessment post-injections was minimal. Amikacin became undetectable within a median of 11 h.
conclusionThe intervention with high-dose amikacin in the 1st week of all-oral regimen was safe in this small cohort. A multi-country study is justified to investigate the efficacy to prevent acquired resistance.
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