Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole + tetracycline ) as second line treatment of H. pylori .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soroka University Medical Center
• Treatments: Amoxicillin; Bismuth; Bismuth subsalicylate; Clarithromycin; Dexlansoprazole; Lansoprazole; Metronidazole; Tetracycline; Tinidazole

Criteria

Inclusion Criteria:

1. signed informed consent

2. age at least 18 years

3. persisting H.pylori infection after at least one course of first-line standard triple therapy (Amoxycillin, Clarithromycin or Metronidazole based)

Exclusion Criteria:

1. history of gastrectomy

2. gastric malignancy, including adenocarcinoma and lymphoma

3. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors

4. Active upper gastrointestinal bleeding within the previous 1 week

5. contraindications to the treatment drugs

6. Pregnant or lactating women

7. Severe concurrent disease or malignancy