title: A prospective evaluation of levofloxacin-based triple therapy for refractory Helicobacter pylori infection in Australia.
abstract: BACKGROUND
  First-line Helicobacter pylori eradication failure is a common and challenging problem.
  
  
  OBJECTIVE
  To assess the efficacy of salvage levofloxacin-based triple therapy in Australia.
  
  
  METHODS
  Prospective patients referred after prior treatment failure(s) were prescribed esomeprazole 40 mg, amoxicillin 1 g and levofloxacin 500 mg each twice daily for 10 days. All patients received detailed written and verbal adherence support. Outcome assessment was by13C-urea breath test and/or histology and urease test.
  
  
  RESULTS
  In 150 consecutive, evaluable patients (66% female, mean age 54 ± 14 years; six smokers), the main indications for treatment were peptic ulcer disease (17%), increased gastric cancer risk (20%), symptoms (35%) and other risk reduction (28%). The median number of previous treatments was 2 (range 1-7). Eradication of H. pylori was achieved in 90% (intention to treat (ITT)) and 91% (per-protocol (PP)) of patients. The eradication rate did not differ according to the type or number of prior treatments: 93% when ≤2 (n = 107) compared with 84% after three or more prior treatments (n = 43; P = 0.13) or with age, ethnicity or indication for treatment but it was higher in females (ITT 94 vs 82%, P = 0.04). Adherence was excellent (95%). No serious adverse effects were observed; mild adverse effects were reported in 11%. No primary levofloxacin resistance was observed in 20 concurrent cases.
  
  
  CONCLUSIONS
  The efficacy and safety of this levofloxacin-based triple therapy suggests it should be used as a salvage regimen in this region. Randomised comparative trials are unlikely to be done but these data compare favourably with local data for other salvage therapies.
authors.affiliation: Gastroenterology Department, Concord Hospital, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Peter H
authors.identifier: http://orcid.org/0000-0001-6969-4328
authors.initials: PH
authors.lastname: Katelaris
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Anthea L
authors.initials: AL
authors.lastname: Katelaris
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001315:Australia / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016879:Salvage Therapy / Q000379:methods*
chemical_list: D000900:Anti-Bacterial Agents; D064704:Levofloxacin
keywords: 
  Helicobacter pylori
  ; antibiotics; stomach and duodenum