Clinical trial: levofloxacin-based quadruple therapy was inferior to traditional quadruple therapy in the treatment of resistant Helicobacter pylori infection Y. K. YEE* ,1 , T. K. CHEUNG* ,1 , K.-M. CHU  , C. K. CHAN*, J. FUNG*, P. CHAN*, D. BUT*, I. HUNG*, A. O. O. CHAN*, M. F. YUEN*, A. HSU* & B. C. Y. WONG* Departments of *Medicine and  Surgery, University of Hong Kong, Hong Kong Correspondence to: Professor B. C. Y. Wong, Department of Medicine, University of Hong Kong, 4 ⁄ F, Professorial Block, Queen Mary Hospital, Hong Kong. E-mail: bcywong@hku.hk 1 These authors contributed equally to this study. Publication data Submitted 12 June 2007 First decision 26 June 2007 Resubmitted 9 July 2007 Accepted 20 July 2007 SUMMARY Background The efficacy of levofloxacin-based quadruple therapy in resistant Helicobacter pylori infection is not known. Aim To test the efficacy of levofloxacin-based quadruple therapy and tradi- tional quadruple therapy in resistant H. pylori infection. Methods One hundred and two patients with resistant H. pylori infection were ran- domized to 1 week of either EBAL (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., amoxicillin 1 g b.d. and levofloxacin 500 mg b.d.) or EBMT (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., met- ronidazole 400 mg t.d.s. and tetracycline 500 mg q.d.s.). 13 C-urea breath test was performed at week 12 to assess post-treatment H. pylori status. Results In intention-to-treat analysis H. pylori eradication was achieved in 37 of 51 (73%) subjects in EBAL and 45 of 51 (88%) subjects in EBMT groups, respectively (P = 0.046). Per-protocol eradication rates of EBAL and EMBT groups were 78% and 94%, respectively (P = 0.030). The intention-to-treat eradication rate was statistically lower for EBAL than EMBT (56% vs. 90%, P = 0.013) among those who had failed more than one course of eradication therapy. Previous levofloxacin triple therapy did not affect the efficacy of either protocol significantly. Conclusions Levofloxacin-based quadruple therapy was inferior to traditional qua- druple therapy for resistant H. pylori infection. Aliment Pharmacol Ther 26, 1063–1067 Alimentary Pharmacology & Therapeutics ª 2007 The Authors 1063 Journal compilation ª 2007 Blackwell Publishing Ltd doi:10.1111/j.1365-2036.2007.03452.x