title: High efficacy of gemifloxacin-containing therapy in Helicobacter Pylori eradication: A pilot empirical second-line rescue therapy.
abstract: BACKGROUND
  Helicobacter pylori (H pylori) is a common gastric pathogen which is associated with chronic gastritis, peptic ulcer, and gastric cancer. It has worldwide distribution with higher incidence in developing countries. Gemifloxacin is a fluoroquinolone antibiotic with documented in vitro activity against H pylori. Considering that there is no clinical data to verify gemifloxacin efficacy in H pylori eradication, this pilot clinical trial was designed.
  
  
  METHODS
  This prospective pilot study was performed during February 2014 to February 2015. A regimen of gemifloxacin (320 mg single dose) plus twice daily doses of amoxicillin1g, bismuth 240 mg, and omeprazole 20 mg for 14 days were prescribed for H pylori infected patients in whom a first-line standard quadruple therapy (clarithromycin-amoxicillin-bismuth-omeprazole) had failed. To confirm H pylori eradication a 13C-urea breath test was performed 4 weeks after treatment.Compliance and incidence of adverse effects were evaluated by questionnaires.
  
  
  RESULTS
  A total of 120 patients were enrolled consecutively; out of which 106 patients achieved H pylori eradication; per-protocol and intention-to-treat eradication rates were 91.4% (95% CI: 85.5-97.6) and 88.3% (95% CI: 75.4-92.4) respectively. Three patients (2.5%) failed to take at least 80% of the drugs and excluded from the final analysis. Adverse effects were reported in 42% of patients, most commonly including nausea (15%) and diarrhea (13.3%), which was intense in 1 patient and led to the discontinuation of treatment. In total, 96.7% (116/120) of the patients took the medications correctly.
  
  
  CONCLUSIONS
  This study revealed that gemifloxacin-containing quadruple therapy provides high H pylori eradication rate (≥90% PP cure rate), and this agent can be included in the list of second-line H pylori therapeutic regimens.
authors.affiliation: Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran and Pharmaceutical Science Research Center (PSRC), School of Pharmacy, Shiraz University of Medical Sciences, Shiraz Professor Alborzi Clinical Microbiology Research Centre, Shiraz University of Medical Sciences, Shiraz, Iran Pharmaceutical Science Research Center (PSRC), School of Pharmacy Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Laleh
authors.initials: L
authors.lastname: Mahmoudi
authors.forename: Shohreh
authors.initials: S
authors.lastname: Farshad
authors.forename: Mehrdad
authors.initials: M
authors.lastname: Seddigh
authors.forename: Paria
authors.initials: P
authors.lastname: Mahmoudi
authors.forename: Fardad
authors.initials: F
authors.lastname: Ejtehadi
authors.forename: Ramin
authors.initials: R
authors.lastname: Niknam
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage*; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000382:microbiology / Q000473:pathology; D005773:Gastroscopy; D000077735:Gemifloxacin; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D009287:Naphthyridines / Q000008:administration & dosage*; D009853:Omeprazole / Q000008:administration & dosage*; D010865:Pilot Projects; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage; D013272:Stomach Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D009287:Naphthyridines; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D009853:Omeprazole; D000077735:Gemifloxacin