Molecular Detection of Antibiotic Resistance and H Pylori Eradication
NCT ID: NCT01168063
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1386 participants
INTERVENTIONAL
2010-02-28
2013-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Helicobacter pilory triple treatment
Triple treatment on this arm is based on results of molecular detection of resistance to antibiotics
Molecular detection of antibiotic resistance
Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole)
Helicobacter pilori standard recommended treatment
H.Pylori Eradication rate with empirical treatment
standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)
2 lines of treatments :
1\) PPI + Amoxicillin + Clarithromycin for 7 days
1\) PPI + Amoxicillin + Metronidazole for 14 days
Interventions
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Molecular detection of antibiotic resistance
Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole)
standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)
2 lines of treatments :
1\) PPI + Amoxicillin + Clarithromycin for 7 days
1\) PPI + Amoxicillin + Metronidazole for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Charles Delchier, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Henri Mondor Hospital
Créteil, , France
Countries
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References
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Breuer T, Graham DY. Costs of diagnosis and treatment of Helicobacter pylori infection: when does choosing the treatment regimen based on susceptibility testing become cost effective? Am J Gastroenterol. 1999 Mar;94(3):725-9. doi: 10.1111/j.1572-0241.1999.00943.x.
Delchier JC, Bastuji-Garin S, Raymond J, Megraud F, Amiot A, Cambau E, Burucoa C; HELICOSTIC Study Group. Efficacy of a tailored PCR-guided triple therapy in the treatment of Helicobacter pylori infection. Med Mal Infect. 2020 Sep;50(6):492-499. doi: 10.1016/j.medmal.2019.06.001. Epub 2019 Jun 27.
Other Identifiers
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P090210
Identifier Type: -
Identifier Source: org_study_id