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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01168063
First received: July 21, 2010
Last updated: November 7, 2013
Last verified: November 2013
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 21, 2010
Last Updated: November 7, 2013
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Communicable Diseases
Helicobacter Infections
Infection
Bacterial Infections
Gram-Negative Bacterial Infections
Amoxicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clarithromycin
Metronidazole
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014