Molecular Detection of Antibiotic Resistance and H Pylori Eradication (HELICOSTIC)
|Helicobacter Pylori Infection||Drug: Molecular detection of antibiotic resistance Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)|
|Study Design:||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|
- 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
- Comparative cost of the two strategies [ Time Frame: at 6 months according to the two strategies ]
|Study Start Date:||February 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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)
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 ….)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168063
|Henri Mondor Hospital|
|Creteil, France, 94010|
|Principal Investigator:||Jean-Charles Delchier, PU-PH||Assistance Publique - Hôpitaux de Paris|