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Completed

NCT Number: NCT01168063

Molecular Detection of Antibiotic Resistance and H Pylori Eradication

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor Hospital

Créteil, 94010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molecular detection of antibiotic resistance

Drug

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)

standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)

Drug

2 lines of treatments :

  • PPI + Amoxicillin + Clarithromycin for 7 days
  • PPI + Amoxicillin + Metronidazole for 14 days

Other names: Standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole ….)

Primary outcomes

  1. 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 outcomes

  1. Comparative cost of the two strategies

    Time frame: at 6 months according to the two strategies

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: HELICOSTIC

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 22, 2010
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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