Molecular Detection of Antibiotic Resistance and H Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

— HELICOSTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168063
• Other study ID #: P090210
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: November 7, 2013
• Start date: February 2010
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1386
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Molecular detection of antibiotic resistance
Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole)
• 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

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Breuer T, Graham DY. Costs of diagnosis and treatment of Helicobacter pylori infection: when does choosing the treatment regimen based on susceptibility testing become cost effective? Am J Gastroenterol. 1999 Mar;94(3):725-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance	at 3 months	No
Secondary	Comparative cost of the two strategies		at 6 months according to the two strategies	No