H. Pylori Infection Clinical Trial
Official title:
Phase IV Study Comparing the Duration of Sequential Therapy
Background: Helicobacter pylori infection has been shown to be associated with the
development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection
could reduce the occurence or recurrence of these diseases. However, the eradication rate of
clarithromycin-based triple therapy has been declining in recent years, probably related to
the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients
would fail from first line standard eradication therapy and need second line rescue therapy.
About 15-30% of patient would fail from second line therapy and need to be rescued with
third line therapy. In recent years, the concept of sequential therapy has been advocated in
the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five
days, followed by a PPI plus clarithromycin and tinidazole for another five days. The
eradication rate in the first line treatment of sequential therapy had been reported to be
as high as 90%. More importantly, it has been demonstrated that the eradication rate among
patients with clarithromycin-resistant strains could be as high as 89%. However, tinidazole
is not available in many countries. Whether metronidazole would be an effective alternative
to tinidazole in the sequential therapy remains unknown. Besides, whether extending the
duration of sequential therapy from 10-day to 14-day would result in higher eradication rate
also deserves further investigation. Furthermore, data on the efficacy of rescue regimens
for patients who failed from first line sequential therapy are also lacking. The impact of
clarithromycin, metronidazole resistance and CYP2C19 polymorphism on the sequential therapy
containing metronidazole (rather than tinidazole) also has not been reported.
Aims: Therefore, we aim to assess
1. whether the substitution of metronidazole for tinidazole in the sequential therapy is
also more effective than clarithromycin-based triple therapy
2. whether extending the duration of sequential therapy from 10-day to 14-day would
achieve higher eradication rate
3. whether levofloxacin-based sequential therapy for 14-days is effective as second line
rescue regimen for those who failed from first line sequential therapy
4. the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of
sequential therapy
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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