Molecular Detection of Antibiotic Resistance and H Pylori Eradication

Study Overview
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Brief Summary
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H pylori eradication failure with recommended triple therapy is mainly related to antibiotic resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine practice. A molecular test of antibiotic resistance easy to perform is now available. The aim of the study was to compare eradication rates obtained with the standard treatment and with a treatment guided by the results of the molecular detection of antibiotic resistance.

Detailed Description
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At the present time, H pylori infection is treated with a standard triple therapy. Treatment of naïve patients with triple therapy ( PPI+amoxicillin+clarithromycin for 7 days) markedly decreased last years to reach 70% due to a clarithromycin resistance rate about 20% in France. In case of failure, the recommended second line treatment (PPI+amoxicillin+metronidazole for 14 days) gives a success rate of 60%. However, as culture is uneasy and is only possible in specialised labs sensitivity to antibiotics is not currently studied before treatment. The aim of the study was to evaluate clinical and medico-economic benefit of the molecular detection of antibiotic resistance in order to guide the treatment. The test is performed after DNA extraction from biopsy specimens taken at gastroscopy allowing rapid detection of H pylori and clarithromycin or quinolone resistance. Patients with bacteriologically proven H pylori infection will be randomly allocated to either empirical usual treatment with PPI , amoxicillin 1g, clarithromycin 500 mg X 2 /day for 7 days in naïve patients and PPI, amoxicillin 1g,metronidazole 500 mg X 2 /day for 14 days in patients who failed a first line treatment , or to treatment guided by the molecular test: PPI , amoxicillin 1g, clarithromycin 500 mg X 2 /day for 7 days in case of sensitivity to clarithromycin.In case of resistance to clarithromycin, quinolone should be given and in case of resistance to quinolone clarithromycin should be given. In case of resistance to both antibiotics metronidazole should be given. Eradication will be assessed by performing 4 weeks after the completion of treatment with Urea Breath Test.

Official Title
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Medico-economic Evaluation of a Therapeutic Strategy Based on Molecular Detection of Antibiotic Resistance in the Management of H Pylori Infection

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Molecular detection of antibiotic resistance
* Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: H pylori infection bacteriologically confirmed Age > 18 years Naïve patient or one failure of the first line recommended treatment Patient referred to one out of the centres participating in the study Exclusion Criteria: H pylori positive patient with at least failure of two lies of treatment patients with previous adverse event with PPI, amoxicillin, clarithromycin, levofloxacin or metronidazole PPI or antibiotic treatment in progressor stopped for less than 4 weeks patient with other severe sickness

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: Helicobacter pilory triple treatment<br>Triple treatment on this arm is based on results of molecular detection of resistance to antibiotics | Drug: Molecular detection of antibiotic resistance<br>* Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole)<br>* Other names: Use of triple therapy base on antibiotics resistances (PPI,amoxicillin,clarithromycin, metronidazole);|
| Active Comparator: Helicobacter pilori standard recommended treatment<br>H.Pylori Eradication rate with empirical treatment | Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)<br>* 2 lines of treatments : 1) PPI + Amoxicillin + Clarithromycin for 7 days 1) PPI + Amoxicillin + Metronidazole for 14 days<br>* Other names: Standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole ….);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori eradication rate (at 3months according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance) | at 3 months according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative cost of the two strategies |  | at 6 months according to the two strategies | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Diagnostic molecular testing, Antibiotic resistance, Treatment protocols