EFFECTIVENESS OF RIMACTAZID FOR ERADICATION OF HELICOBACTER PYLORI IN RESISTANT CASES: A RANDOMIZED CONTROLLED CLINICAL STUDY
DOI:
https://doi.org/10.48047/6hd7mf50Keywords:
Helicobacter pylori, Antibiotic Resistance, Rifampicin, Isoniazid, Rimactazid, Rescue TherapyAbstract
Background: The global rise in antibiotic resistance to Helicobacter pylori has markedly reduced the efficacy of standard eradication regimens. Rifamycin-based treatments constitute optimistic recovery options owing to their low propensity for resistance. Rimactazid (a fixed-dose combination of rifampicin and isoniazid) is broadly accessible and exhibits strong intracellular antibacterial efficacy; however, its clinical application in H. pylori eradication has not been sufficiently studied. We aimed to assess the efficacy and safety of a Rimactazid-based triple therapy for eradication of H. pylori infection in cases with documented resistance or at least two previous eradication regimens failure.
Methods: In this prospective randomized controlled trial, individuals with refractory H. pylori infection were allocated to receive either Rimactazid-based triple therapy or a rifabutin-based rescue regimen. Eradication was evaluated by the 13C-urea breath test 8 weeks following therapy. Intention-to-treat (ITT) and per-protocol (PP) analyses were used. Results: Two hundred and twelve cases were randomized (106 per group). Eradication rates were significantly elevated in the Rimactazid group (ITT: 82.1%; PP: 86.7%) compared with the control group (ITT: 68.9%; PP: 73.5%). Adverse events were mild and comparable among groups.
Conclusions: Rimactazid-based triple treatment is a highly effective and well-tolerated rescue regimen for resistant H. pylori infections eradication.
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