Second-line rescue therapy with levofloxacin after H. pylori treatment failure: a Spanish multicenter study of 300 patients

Am J Gastroenterol. 2008 Jan;103(1):71-6. doi: 10.1111/j.1572-0241.2007.01500.x. Epub 2007 Aug 31.


Aim: Quadruple therapy is generally recommended as second-line therapy after Helicobacter pylori (H. pylori) eradication failure. However, this regimen requires the administration of four drugs with a complex scheme, is associated with a relatively high incidence of adverse effects, and bismuth salts are not available worldwide anymore. Our aim was to evaluate the efficacy and tolerability of a triple second-line levofloxacin-based regimen in patients with H. pylori eradication failure.

Design: Prospective multicenter study.

Patients: in whom a first treatment with proton pump inhibitor-clarithromycin-amoxicillin had failed.

Intervention: A second eradication regimen with levofloxacin (500 mg b.i.d.), amoxicillin (1 g b.i.d.), and omeprazole (20 mg b.i.d.) was prescribed for 10 days.

Outcome: Eradication was confirmed with (13)C-urea breath test 4-8 wk after therapy. Compliance with therapy was determined from the interview and the recovery of empty envelopes of medications. Incidence of adverse effects was evaluated by means of a specific questionnaire.

Results: Three hundred consecutive patients were included. Mean age was 48 yr, 47% were male, 38% had peptic ulcer, and 62% functional dyspepsia. Almost all (97%) patients took all the medications correctly. Per-protocol and intention-to-treat eradication rates were 81% (95% CI 77-86%) and 77% (73-82%). Adverse effects were reported in 22% of the patients, mainly including nausea (8%), metallic taste (5%), abdominal pain (3%), and myalgias (3%); none of them were severe.

Conclusion: Ten-day levofloxacin-based rescue therapy constitutes an encouraging second-line strategy, representing an alternative to quadruple therapy in patients with previous proton pump inhibitor-clarithromycin-amoxicillin failure, being simple and safe.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amoxicillin / therapeutic use*
  • Anti-Bacterial Agents / therapeutic use*
  • Breath Tests
  • Clarithromycin / therapeutic use
  • Drug Therapy, Combination
  • Endoscopy, Gastrointestinal
  • Female
  • Follow-Up Studies
  • Gastric Mucosa / microbiology
  • Gastric Mucosa / pathology
  • Helicobacter Infections / diagnosis
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / microbiology
  • Helicobacter pylori / drug effects
  • Helicobacter pylori / isolation & purification*
  • Humans
  • Levofloxacin*
  • Male
  • Middle Aged
  • Ofloxacin / therapeutic use*
  • Omeprazole / therapeutic use*
  • Prospective Studies
  • Proton Pump Inhibitors / therapeutic use
  • Treatment Failure
  • Urea / analysis


  • Anti-Bacterial Agents
  • Proton Pump Inhibitors
  • Levofloxacin
  • Amoxicillin
  • Urea
  • Ofloxacin
  • Clarithromycin
  • Omeprazole