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The goal of first‐line Helicobacter pylori therapy is to reach an eradication rate of 90% to avoid further investigations, antibiotic use, and spreading of resistant strains.
Aim
To evaluate the eradication rate of high‐dose sequential therapy in treatment‐naïve children and to assess factors associated with failure.
Methods
Prospective data assessed in a registry from nine European centers between October 2009 and December 2011. Children with biopsy‐proven Helicobacter pylori infection were prescribed 5 days of esomeprazole and amoxicillin, followed by 5 days of esomeprazole, clarithromycin, and metronidazole according to bodyweight. Eradication was assessed after 8–12 weeks. Primary endpoint was the eradication rate in children who received at least one dose and had follow‐up data. Multivariate analysis evaluated potential factors for treatment success including sex, age, center, migrant status, antibiotic resistance, and adherence to therapy.
Results
Follow‐up was available in 209 of 232 patients (age range 3.1–17.9 years, 118 females). Primary resistance occurred for clarithromycin in 30 of 209 (14.4%), for metronidazole in 32 (15.3%), for both antibiotics in 7 (3.3%), and culture failed in 6 (2.9%). Eradication was achieved in 168 of 209 children (80.4%, 95% CI 75.02–85.78), in 85.8% with no resistance, 72.6% with single resistance, and 28.6% with double resistance. Independent factors affecting eradication rate included resistance to clarithromycin (adjusted ORs 0.27 (0.09–0.84), p = .024), to metronidazole (0.25 (0.009–0.72), p = .010) or to both (0.04 (0.01–0.35), p = .004), and intake of ≤90% of prescribed drugs (0.03 (0.01–0.18), p < .001).
Conclusion
A high‐dose 10‐day sequential therapy cannot be recommended in treatment‐naïve children.