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Clinical trial

Personalized Treatment for Refractory H Pylori Infection

ID
Name
VGHKS13-CT12-17
Description
In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.
Trial arms
Trial start
2012-08-01
Estimated PCD
2021-10-31
Trial end
2021-10-31
Status
Completed
Treatment
rabeprazole+3 antibiotics
(rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.
Arms:
rabeprazole+3 antibiotics
Other names:
rabeprazole 20 mg, amoxicillin 1g, clarithromycin 500mg, metrondazole 250mg, tetracycline 500mg, levofloxacin 500mg
rabeprazole+bismuth+2 antibiotics
(rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.
Arms:
rabeprazole+bismuth+2 antibiotics
Other names:
rabeprazole 20 mg, bismuth subcitrate 120 mg, amoxicillin 1g, clarithromycin 500mg, metrondazole 250mg, tetracycline 500mg, levofloxacin 500mg
rabeprazole+amox+tetr+levo
(rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.
Arms:
rabeprazole+amox+tetr+levo
Other names:
rabeprazole 20 mg, bismuth subcitrate 120 mg, tetracycline 500mg, levofloxacin 500mg
Size
126
Primary endpoint
Number of Participants in Which H. Pylori Was Eradicated
eight weeks after the end of anti-H pylori therapy
Eligibility criteria
Inclusion Criteria: H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent. * positive results of both rapid urease test and histology, * a positive result of Urea breath test, * or a positive result of culture Exclusion Criteria: * ingestion of antibiotics, bismuth, or proton-pump inhibitor 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 126, 'type': 'ACTUAL'}}
Updated at
2023-10-26

1 organization

3 products

1 indication

Organization
Kaohsiung Veterans General Hospital
Product
Rabeprazole + 3 antibiotics
Indication
Helicobacter pylori infection
Product
Rabeprazole + Bismuth + 2 Antibiotics
Product
rabeprazole+amox+tetr+levo