Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication
Summary
Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-10
- Completion
- 2012-12
Outcome
Missed primary endpoint
paper The PP eradication rates of the SEQ and QUAD groups were 95.2% and 98.8%, respectively (p=0.10). PMID 24295850 ↗
paper Based on ITT analysis, the corresponding eradication rates were 89.4% and 92.7%, respectively (p=0.36). PMID 24295850 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 1 g | — |
| Subject | Bismuth subcitrate | Unknown | 120 mg | — |
| Subject | Clarithromycin | Small molecule | 500 mg | — |
| Subject | Metronidazole | Small molecule | 400 mg | — |
| Subject | Tetracycline | Unknown | 500 mg | — |
| Background | Esomeprazole | Small molecule | 20 mg | — |