title: New effective treatment regimen for children infected with a double-resistant Helicobacter pylori strain.
abstract: BACKGROUND
  The increasing number of pediatric patients infected with multiresistant Helicobacter pylori strains calls for evaluation of treatment regimens. Second-line antibiotics such as tetracycline or quinolones are not licensed for children. Because in vivo resistance to metronidazole may be overcome in vivo by a high dose and prolonged intake, we evaluated the eradication rate and side effects of a high-dose triple therapy in pediatric patients with culture-proven double resistance.
  
  
  METHODS
  In this open multicentre trial, 62 children (<18 years, body weight >15 kg) infected with an H pylori strain resistant to metronidazole and clarithromycin were treated according to body weight classes with amoxicillin (∼ 75 mg/kg/day), metronidazole (∼ 25 mg/kg/day) and esomeprazole (∼ 1.5 mg/kg/day) for 2 weeks. Adherence and adverse events were assessed by a 2-week diary and telephone interviews at days 7 and 14 of treatment. Primary outcome was a negative C-urea breath test after 6 weeks.
  
  
  RESULTS
  Of 62 patients, 5 were lost to follow-up, 12 were nonadherent, and 45 treated per protocol. Eradication rates were 66% (41/62) [confidence interval 54-78] (intention to treat) and 73% (33/45) [confidence interval 60-86] (per protocol). Success of treatment was not related to dose per kilogram body weight. Mild to moderate adverse events were reported by 21 patients, including nausea (10.8%), diarrhoea (8.9%), vomiting (7.1%), abdominal pain (5.4%), and headache (3.6%), and led to discontinuation in 1 child.
  
  
  CONCLUSIONS
  High-dose amoxicillin, metronidazole, and esomeprazole for 2 weeks is a good treatment option in children infected with a double resistant H pylori strain.
authors.affiliation: Dr von Haunersches Kinderspital, Munich, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Schwarzer
authors.forename: P
authors.initials: P
authors.lastname: Urruzuno
authors.forename: B
authors.initials: B
authors.lastname: Iwańczak
authors.forename: M Z
authors.initials: MZ
authors.lastname: Martínez-Gómez
authors.forename: N
authors.initials: N
authors.lastname: Kalach
authors.forename: E
authors.initials: E
authors.lastname: Roma-Giannikou
authors.forename: S
authors.initials: S
authors.lastname: Liptay
authors.forename: P
authors.initials: P
authors.lastname: Bontem
authors.forename: S
authors.initials: S
authors.lastname: Buderus
authors.forename: T G
authors.initials: TG
authors.lastname: Wenzl
authors.forename: S
authors.initials: S
authors.lastname: Koletzko
mesh_terms: D000293:Adolescent; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D024901:Drug Resistance, Multiple, Bacterial; D004359:Drug Therapy, Combination / Q000009:adverse effects; D064098:Esomeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005060:Europe; D005260:Female; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D059012:Lost to Follow-Up; D008297:Male; D055118:Medication Adherence; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008826:Microbial Sensitivity Tests
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; D000658:Amoxicillin; D064098:Esomeprazole