An interventional study of Molecular detection of antibiotic resistance and standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole) in Helicobacter Pylori Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 1,386 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Triple treatment on this arm is based on results of molecular detection of resistance to antibiotics
Drug: Molecular detection of antibiotic resistance
H.Pylori Eradication rate with empirical treatment
Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)
Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole)
Also known as: Helicobacter Molecular detection of resistance to clarithromycin and quinolones, Use of triple therapy base on antibiotics resistances (PPI,amoxicillin,clarithromycin, metronidazole)
2 lines of treatments : 1) PPI + Amoxicillin + Clarithromycin for 7 days 1) PPI + Amoxicillin + Metronidazole for 14 days
Also known as: Standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole ….)
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
Time frame: at 3 months
Comparative cost of the two strategies
Time frame: at 6 months according to the two strategies
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris