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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00457-42 | Other Identifier | IDRCB |
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The H pylori infection remains a public health problem. The eradication rate with the first line triple therapy (PPI-amoxicillin-clarithromycin) is insufficient (estimated at 70%) due to the frequency of resistance to clarithromycin, which reaches 21% in France. Until now,European and French consensus recomended tofavor sequential therapy (5 days PPI-amoxicillin and 5 days PPI-clarithromycin-metronidazole) or quadruple bismuth therapy ( 10 days PPI-tetracyclin,-metronidazole- bismuth). Studies in countries with low prevalence of clarithromycin resistance reported eradication rate of 85% with sequential therapy and reported a low impact of clarithromycin resistance on the effectiveness of this treatment. However, recent studies suggest a greater impact of clarithromycin resistance. Recent meta-analysis shows that empiric sequential therapy is less efficacious than concomitant quadruple therapy. Therefore, recent Maastricht V / Florence meeting October 7-8 2015) recommended to abandon sequential therapy and to favor 14 days concomitant therapy in first line in order to reach an eradication rate >90%.
In a multicenter randomized clinical trial (HELICOSTIC 2010-2011 AO ICST 2009), we compared a triple therapy guided by the results of a PCR test that detects resistance to clarithromycin and levofloxacin (HelicoDR ®) to empirical triple therapy (PPI-amoxicillin-clarithromycin). 1384 patients and among them 526 infected patients were enrolled in 10 centers. The results in 415 patients were 73.1% for the empirical treatment versus 85.5% (p <0.001) for the treatment guided by PCR HelicoDR®. This study also demonstrated the limits of the test HelicoDR®: onerous, possibility of contamination, little practical contribution of the determination of resistance to quinolones.
Moreover, it has been shown that triple therapy efficiency could be optimized by increasing duration up to 14 days and increasing dose of PPI to 40mg b.d;.and eradications rates > 90% were reported with susceptible to clarithromycin strains.
Adverse events are less common with optimized triple therapy than with concomitant quadruple therapy.
The main objective is to compare the efficacy of optimized triple therapy guided by the results of a PCR test (eradication rates 90% hypothesized) with quadruple concomitant therapy (eradication rate 90% hypothesized).
The secondary objective is to determine side effects of optimized guided triple therapy as well as the quadruple concomitant therapy in France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple therapy guided by result of the molecular resistance | Experimental |
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| Quadruple concomitant therapy | Active Comparator | high dose PPI (Esoméprazole 40 mg X 2 / d- amoxicillin 1gX2 / d - - clarithromycin 500mgX2 / d - metronidazole 500mgX2 / d for 14 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadruple concomitant therapy treatment | Other | Quadruple concomitant therapy treatment: high dose PPI (Esoméprazole 40 mg X 2 / d- amoxicillin 1gX2 / d - - clarithromycin 500mgX2 / d - metronidazole 500mgX2 / d for 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate on the basis of a negative C13 - urea breath test done 6-12 weeks after the end of treatment | Eradication rates will be compared between the patients allocated to standard treatment currently recommended (quadruple concomitant treatment, control group) and patients allocated to triple therapy chosen according to the results of molecular detection of clarithromycin resistance (guided triple therapy,, test group). The breath test is recognized as a sensitive and specific test for infection with H. pylori, particularly in the context of monitoring the efficacy of treatment. It will be carried out blindly to allocated group. | at 34 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety criteria will include all adverse events occurring in the two treatment groups | at 34 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Charles Delchier, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Recruiting | Créteil | 94010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38680067 | Derived | Amiot A, Hacoon J, Heluwaert F, Mion F, Lamarque D, Moussata D, Mimouni M, Delchier JC, Durand-Zaleski I, Audureau E, Bastuji-Garin S; HEPYSE Study Group. 14-day tailored PCR-guided triple therapy versus 14-day non-Bismuth concomitant quadruple therapy for Helicobacter pylori eradication: A multicenter, open-label randomized noninferiority controlled trial. Helicobacter. 2024 Mar-Apr;29(2):e13076. doi: 10.1111/hel.13076. |
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| Triple therapy guided by the result of the molecular resistance test | Other | Triple therapy guided by the result of the molecular resistance test:
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| ID | Term |
|---|---|
| D003033 | Coal Tar |
| ID | Term |
|---|---|
| D013638 | Tars |
| D045424 | Complex Mixtures |
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