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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole); Drug: Molecular detection of antibiotic resistance

Study type: Interventional

Funder types: Other

Identifiers

NCT01168063

P090210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,386 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,386 participants in 2 patient groups

Helicobacter pilory triple treatment

Experimental group

Description:

Triple treatment on this arm is based on results of molecular detection of resistance to antibiotics

Treatment:

Drug: Molecular detection of antibiotic resistance

Helicobacter pilori standard recommended treatment

Active Comparator group

Description:

H.Pylori Eradication rate with empirical treatment

Treatment:

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