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Molecular Detection of Antibiotic Resistance and H Pylori Eradication (HELICOSTIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168063
First Posted: July 22, 2010
Last Update Posted: November 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Helicobacter Pylori Infection Drug: Molecular detection of antibiotic resistance Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medico-economic Evaluation of a Therapeutic Strategy Based on Molecular Detection of Antibiotic Resistance in the Management of H Pylori Infection

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • H. pylori eradication rate (at 3months according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance) [ Time Frame: at 3 months ]
    at 3 months according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance


Secondary Outcome Measures:
  • Comparative cost of the two strategies [ Time Frame: at 6 months according to the two strategies ]

Enrollment: 1386
Study Start Date: February 2010
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Helicobacter pilory triple treatment
Triple treatment on this arm is based on results of molecular detection of resistance to antibiotics
Drug: Molecular detection of antibiotic resistance
Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole)
Other Names:
  • Helicobacter Molecular detection of resistance to clarithromycin and quinolones
  • Use of triple therapy base on antibiotics resistances (PPI,amoxicillin,clarithromycin, metronidazole)
Active Comparator: Helicobacter pilori standard recommended treatment
H.Pylori Eradication rate with empirical treatment
Drug: 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 Name: Standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole ….)

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168063


Locations
France
Henri Mondor Hospital
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Charles Delchier, PU-PH Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01168063     History of Changes
Other Study ID Numbers: P090210
First Submitted: July 21, 2010
First Posted: July 22, 2010
Last Update Posted: November 8, 2013
Last Verified: November 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Helicobacter pylori
Diagnostic molecular testing
Antibiotic resistance
Treatment protocols

Additional relevant MeSH terms:
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Amoxicillin
Clarithromycin
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors