{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T13:15:37Z","timestamp":1789564537446,"version":"build-2803163510"},"reference-count":22,"publisher":"International Union Against Tuberculosis and Lung Disease","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJTLD Open"],"accepted":{"date-parts":[[2025,7,22]]},"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>SUMMARY<\/jats:title>\n                  <jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>Effective 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>In 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\u20134 amikacin-related adverse event, corresponding to a primary hypothesis that less than 14% of patients have a grade 3\u20134 adverse event related to amikacin. Nephrotoxicity, ototoxicity, and pain post-injection were monitored. Early bactericidal effect and amikacin pharmacokinetics were measured.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>None of the 20 patients experienced a grade 3\u20134 adverse event during the first 2 weeks of treatment (95% confidence interval: 0\u20130.139). No hearing loss of any grade was observed. Pain assessment post-injections was minimal. Amikacin became undetectable within a median of 11 h.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>The 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.5588\/ijtldopen.25.0120","type":"journal-article","created":{"date-parts":[[2025,11,13]],"date-time":"2025-11-13T04:34:41Z","timestamp":1763008481000},"page":"655-661","source":"Crossref","is-referenced-by-count":2,"title":["High-dose amikacin in the first week of all-oral rifampicin-resistant TB treatment is safe: a single-arm 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Surrey, UK: Hospira UK Ltd, 2024. https:\/\/www.medicines.org.uk\/emc\/product\/3784\/smpc#gref."},{"issue":"12","key":"2026011502264488000_2.11.655.19","doi-asserted-by":"crossref","first-page":"1199","DOI":"10.1097\/INF.0000000000001983","article-title":"Effect of coadministration of lidocaine on the pain and pharmacokinetics of intramuscular amikacin in children with multidrug-resistant tuberculosis: a randomized crossover trial","volume":"37","author":"Garcia-Prats","year":"2018","journal-title":"Pediatr Infect Dis J"},{"issue":"8","key":"2026011502264488000_2.11.655.20","doi-asserted-by":"crossref","first-page":"926","DOI":"10.5588\/ijtld.18.0091","article-title":"Effect of lidocaine on kanamycin injection-site pain in patients with multidrug-resistant tuberculosis","volume":"22","author":"Court","year":"2018","journal-title":"Int J Tuberc Lung Dis"},{"key":"2026011502264488000_2.11.655.21","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2021.115397"},{"key":"2026011502264488000_2.11.655.22","doi-asserted-by":"publisher","DOI":"10.1136\/ejhpharm-2022-003421"}],"container-title":["IJTLD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.5588\/ijtldopen.25.0120","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T10:27:37Z","timestamp":1768472857000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.theunion.org\/lookup\/doi\/10.5588\/ijtldopen.25.0120"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11]]},"references-count":22,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2025,11,1]]},"published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.5588\/ijtldopen.25.0120"],"URL":"https:\/\/doi.org\/10.5588\/ijtldopen.25.0120","relation":{},"ISSN":["3005-7590"],"issn-type":[{"value":"3005-7590","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11]]}}}