Sequential and Hybrid Therapies for H Pylori Infection

Phase 4

Completed

Interventions: Drug: 14-day sequential treatment
Drug: 14-day hybrid treatment

Brief Summary: Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.

Detailed Description: The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.

A total of 240 subjects will be asked to participate in this study.

H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).

Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.

A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.

Recruitment & Eligibility

Inclusion Criteria

consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria

previous H. pylori-eradication therapy
ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
patients with allergic history to the medications used
patients with previous gastric surgery
the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
pregnant women.

Arm && Interventions

Group	Intervention	Description
14-day sequential treatment	14-day sequential treatment	One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
14-day hybrid treatment	14-day hybrid treatment	esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days

Primary Outcome Measures

Name	Time	Method
Number of Participants in Which H. Pylori Was Eradicated	Dec 2010	evaluate eradication outcome by endoscopy with urease test or urea breath test

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Dec 2010	by standardized questionnaire
Compliance Rate	Dec 2010	Good compliance is defined as taking equal or more than 90% of eradication medicines