title: Clarithromycin for first-line treatment of Helicobacter pylori infection after culture in high-resistance regions.
abstract: OBJECTIVE
  Resistance to antibiotics is the major cause of treatment failure of Helicobacter pylori (HP) infection. The culture-guided triple therapy (chosen on the basis of a preliminary in-vitro susceptibility test) might help to increase treatment success in high antibiotic resistance regions. The aim of this study was to evaluate the effectiveness of treatment with clarithromycin in patients with clarithromycin-sensitive culture compared with patients treated empirically.
  
  
  METHODS
  In this prospective and controlled trial, 111 naive HP-positive patients were randomized to receive standard triple therapy omeprazole (20 mg twice daily), amoxicillin (1 g twice daily), and clarithromycin (500 mg twice daily) for 10 days (OAC) after antimicrobial susceptibility testing if there was no resistance to clarithromycin (ClariS) or empirical 10-day OAC for first-line therapy of HP (ClariNA). Eradication was confirmed using the C-labelled urea breath test 6 weeks after therapy. Our primary outcome was HP eradication. Treatment adherence and adverse effects were recorded.
  
  
  RESULTS
  The effectiveness of eradication by protocol with 10-day OAC therapy in the ClariS was 94% [95% confidence interval (CI): 0.83-0.98], which was 22% higher than ClariNA 72% (95% CI: 0.58-0.85; P=0.006). The odds ratio of eradication in ClariS was 1.30 (95% CI: 1.10-1.60; P<0.05 by logistic regression) and the number needed to treat was 5 (95% CI: 3-13). We found no significant difference in the occurrence of adverse effects or in compliance between the two groups.
  
  
  CONCLUSIONS
  The eradication rate was significantly higher with clarithromycin-based triple therapy for patients with clarithromycin-susceptible HP isolates compared with those for whom no information on the corresponding susceptibility was available (ClinicalTrials.gov number NCT01486082).
authors.affiliation: aDepartment of Gastroenterology, University of Basque Country (UPV/EHU), Centro de Investigación Biomédica en Enfermedades Hepáticas y Digestivas (CIBERehd) bDepartment of Microbiology cDepartment of Epidemiology, CIBERESP, Donostia Hospital, Institute Biodonostia, San Sebastián, Spain.
authors.forename: Maider
authors.initials: M
authors.lastname: Martos
authors.forename: Luis
authors.initials: L
authors.lastname: Bujanda
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Salicio
authors.forename: Cristina
authors.initials: C
authors.lastname: Sarasqueta
authors.forename: Begoña
authors.initials: B
authors.lastname: Ibarra
authors.forename: Usua
authors.initials: U
authors.lastname: Mendarte
authors.forename: María
authors.initials: M
authors.lastname: Fernández-Reyes
authors.forename: Angel
authors.initials: A
authors.lastname: Cosme
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001944:Breath Tests; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D011237:Predictive Value of Tests; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D012074:Remission Induction; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole