Sequential and Hybrid Therapies for H Pylori Infection

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Veterans General Hospital.
• Collaborators: Baylor College of Medicine; Kaohsiung Medical University
• Treatments: Amoxicillin; Clarithromycin; Esomeprazole; Metronidazole

Criteria

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.