Rescue Therapy for Helicobacter Pylori Infection

Study Overview
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Brief Summary
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Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus 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 Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Vonoprazan
* Drug: Bismuth Potassium Citrate
* Drug: Tetracycline
* Drug: Metronidazole
* Drug: Amoxicillin
* Drug: 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: subjects naive to H. pylori treatment, under 18 or over 80 years old history of gastrectomy pregnant or lactating women Previous history of tuberculosis Allergy to any of the study drugs severe systemic diseases or malignancy administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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>Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid | Drug: Vonoprazan<br>* Proton pump inhibitor<br>Drug: Bismuth Potassium Citrate<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Tetracycline<br>* Antibiotics for H. pylori eradication<br>Drug: Metronidazole<br>* Antibiotics for H. pylori eradication<br>|
| Experimental: Rifabutin Triple Therapy<br>Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid | Drug: Vonoprazan<br>* Proton pump inhibitor<br>Drug: Amoxicillin<br>* Antibiotics for H. pylori eradication<br>Drug: Rifabutin<br>* Antibiotics for H. pylori eradication<br>|
| Experimental: Dual Therapy<br>Vonoprazan 20mg bid, amoxicillin 1000mg tid | Drug: Vonoprazan<br>* Proton pump inhibitor<br>Drug: Amoxicillin<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 defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value). | Six weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse effects | The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as mild (transient and well tolerated), moderate (causing discomfort and partially interfering with daily activities), or severe (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney. | Within 7 days after completion of therapy | 
| 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, rescue therapy