HELICOSTIC: Molecular Detection of Antibiotic Resistance and H Pylori Eradication

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01168063

Collaborator

(none)

1,386

Enrollment

Location

Arms

36.9

Duration (Months)

37.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Molecular detection of antibiotic resistance Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1386 participants

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole ….)

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

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) [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 [at 6 months according to the two strategies]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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