High-dose amikacin in the first week of all-oral rifampicin-resistant TB treatment is safe: a single-arm trial.

ABSTRACT:

Background

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.

Methods

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 3-4 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

SUBMITTER: Snobre J 

PROVIDER: S-EPMC12617081 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature