Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection

Study Overview
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Brief Summary
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The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.

Detailed Description
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Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies. H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.

Official Title
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Eradication Efficacy and Safety of High-dose Dual Therapy Compared With Furazolidone-based Quadruple Therapy as a Rescue Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial

Conditions
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H. Pylori Infection

Intervention / Treatment
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* Drug: esomeprazole plus amoxicillin
* Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole. Exclusion Criteria: Age < 18 years old. The time frame was less than 6 months from the previous eradication therapy. The previous eradication therapy included furazolidone. Allergic to the medication. Pregnant or lactating women. Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseases or malignancy. Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: High-dose dual therapy group<br>esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group | Drug: esomeprazole plus amoxicillin<br>* amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days<br>* Other names: HDDT;|
| Active Comparator: Furazolidone-based quadruple therapy<br>furazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy | Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole<br>* amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days<br>* Other names: FT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eradication rate | eradication rate of H pylori, presenting with negative results on the 13C-UBT test | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of the adverse events | incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever. | 42 days | 
| compliance rate of the drugs | Compliance was defined as good when they had taken more than 80% of the total medication. | 42 days |