Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

Study Overview
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Brief Summary
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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

Official Title
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Rifabutin-containing Triple Therapy for Rescue Treatment of Helicobacter Pylori: A Randomized Clinical Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Bismuth Potassium Citrate
* Drug: Tetracycline,Metronidazole
* Drug: amoxicillin rifabutin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ability and willingness to participate in the study and to sign and give informed consent Confirmed H. pylori infection and with previous treatment experience Exclusion Criteria: Less than 18 years old With previous gastric surgery Previous history of tuberculosis Major systemic diseases Pregnancy or lactation Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tetracycline Bismuth Quadruple Therapy<br>Esomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid | Drug: Esomeprazole<br>* Proton pump inhibitor<br>Drug: Bismuth Potassium Citrate<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Tetracycline,Metronidazole<br>* Antibiotics for H. pylori eradication<br>|
| Experimental: rifabutin triple therapy<br>Esomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid | Drug: Esomeprazole<br>* Proton pump inhibitor<br>Drug: amoxicillin rifabutin<br>* Antibiotics for H. pylori eradication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was | Six weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rate | Compliance was defined as poor when they had taken less than 80% of the total medication | Within 7 days after completion of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori Therapy