Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori
Study Details
Study Description
Brief Summary
Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Tetracycline Bismuth Quadruple Therapy Esomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid |
Drug: Esomeprazole
Proton pump inhibitor
Drug: Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Drug: Tetracycline,Metronidazole
Antibiotics for H. pylori eradication
|
Experimental: rifabutin triple therapy Esomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid |
Drug: Esomeprazole
Proton pump inhibitor
Drug: amoxicillin rifabutin
Antibiotics for H. pylori eradication
|
Outcome Measures
Primary Outcome Measures
- Helicobacter pylori eradication rate [Six weeks after completion of therapy]
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was
Secondary Outcome Measures
- Compliance rate [Within 7 days after completion of therapy]
Compliance was defined as poor when they had taken less than 80% of the total medication
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ability and willingness to participate in the study and to sign and give informed consent
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Confirmed H. pylori infection and with previous treatment experience
Exclusion Criteria:
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Less than 18 years old
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With previous gastric surgery
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Previous history of tuberculosis
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Major systemic diseases
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Pregnancy or lactation
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Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai | China | 200127 |
Sponsors and Collaborators
- Shanghai Jiao Tong University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- rjcjn20210506