title: Evaluation of two triple-therapy regimens with metronidazole or clarithromycin for the eradication of H. pylori infection in Vietnamese children: a randomized, double-blind clinical trial.
abstract: BACKGROUND
  Eradication of Helicobacter pylori infection in children in developing countries needs further investigations upon which to base treatment recommendations. The aim of the study was to compare two 2-week triple therapies in a randomized double-blind trial.
  
  
  METHODS
  In order not to exceed recommended dosages, the 238 H. pylori-infected children, aged 3 to 15 years (mean 8.6), were divided in two weight categories receiving at weights 13-22 kg: lansoprazole 15 mg once-daily and amoxicillin 500 mg twice-daily with metronidazole 250 mg twice-daily or clarithromycin 250 mg once-daily; at weights 23-45 kg: lansoprazole 15 mg and amoxicillin 750 mg with metronidazole 500 mg or clarithromycin 250 mg, all administered twice daily. H. pylori status was assessed by culture and a monoclonal-based antigen-in-stool test (Premier Platinum HpSA PLUS) and side effects by structured questionnaires.
  
  
  RESULTS
  The overall per-protocol eradication (n = 233) was similar in the two treatment regimens, 62.1% for the metronidazole and 54.7% for the clarithromycin-containing therapy. Eradication rate was higher in children >or= 23 kg (70.9%) than in children < 23 kg (45.7%). In children >or= 23 kg (n = 117) that received twice-daily administration of all drugs, efficacy of the metronidazole and clarithromycin-containing treatments were 69.5% and 72.4%, respectively.
  
  
  CONCLUSIONS
  The two treatments gave similar eradication rates. Significant differences for both treatments were found by weight, which could be the result of the once-daily proton pump inhibitor and clarithromycin and/or more antibiotic resistant strains in younger children.
authors.affiliation: Unit of Clinical Microbiology, Department of Microbiology, Tumor and Cell Biology (MTC) Karolinska Institutet and Clinical Microbiology, Karolinska University Hospital, Solna, Sweden.
authors.forename: Thi Viet Ha
authors.initials: TV
authors.lastname: Nguyen
authors.forename: Carina
authors.initials: C
authors.lastname: Bengtsson
authors.forename: Gia Khanh
authors.initials: GK
authors.lastname: Nguyen
authors.forename: Thi Thu Ha
authors.initials: TT
authors.lastname: Hoang
authors.forename: Dac Cam
authors.initials: DC
authors.lastname: Phung
authors.forename: Mikael
authors.initials: M
authors.lastname: Sörberg
authors.forename: Marta
authors.initials: M
authors.lastname: Granström
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000293:Adolescent; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000942:Antigens, Bacterial / Q000032:analysis; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005243:Feces / Q000737:chemistry; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013270:Stomach / Q000382:microbiology; D014744:Vietnam
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D000942:Antigens, Bacterial; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin