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.
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.
Nguyen
Thi Viet Ha
TV
Unit of Clinical Microbiology, Department of Microbiology, Tumor and Cell Biology (MTC) Karolinska Institutet and Clinical Microbiology, Karolinska University Hospital, Solna, Sweden.
Bengtsson
Carina
C
Nguyen
Gia Khanh
GK
Hoang
Thi Thu Ha
TT
Phung
Dac Cam
DC
Sörberg
Mikael
M
Granström
Marta
M
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
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D000942:Antigens, Bacterial; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin