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Therapeutic Trial Comparing Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance vs Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection (Hepysé)

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ClinicalTrials.gov Identifier: NCT02576236
Recruitment Status : Unknown
Verified June 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : October 15, 2015
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
H Pylori Infection Eradication Antibiotics Therapeutic Strategies H Pylori Eradication Other: Quadruple concomitant therapy treatment Other: Triple therapy guided by the result of the molecular resistance test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Tolerance of Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance WITH Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection: a Randomised Multicentre Trial
Actual Study Start Date : May 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Triple therapy guided by result of the molecular resistance
  • If clarithromycin S : high dose PPI (Esoméprazole 40mg X 2/ d) - amoxicillin 1gX2 / d - clarithromycin 500mgX2 / d The total duration of treatment is 14 days.
  • If clarithromycin R: high dose PPI (Esoméprazole 40mg X 2/ d) - amoxicillin 1gX2 / d- levofloxacin 500mg X2 / d The total duration of treatment is 14 days.
Other: Triple therapy guided by the result of the molecular resistance test

Triple therapy guided by the result of the molecular resistance test:

  • If clarithromycin S : high dose PPI (Esoméprazole 40mg X 2/ d) - amoxicillin 1gX2 / d - clarithromycin 500mgX2 / d The total duration of treatment is 14 days.
  • If clarithromycin R: high dose PPI (Esoméprazole 40mg X 2/ d) - amoxicillin 1gX2 / d- levofloxacin 500mg X2 / d The total duration of treatment is 14 days.
Other Name: therapeutic procedure

Active Comparator: Quadruple concomitant therapy
high dose PPI (Esoméprazole 40 mg X 2 / d- amoxicillin 1gX2 / d - - clarithromycin 500mgX2 / d - metronidazole 500mgX2 / d for 14 days
Other: Quadruple concomitant therapy treatment

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

Other Name: therapeutic procedure




Primary Outcome Measures :
  1. Eradication rate on the basis of a negative C13 - urea breath test done 6-12 weeks after the end of treatment [ Time Frame: at 34 month ]
    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.


Secondary Outcome Measures :
  1. Safety criteria will include all adverse events occurring in the two treatment groups [ Time Frame: at 34 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients ≥ 18 years
  • Hospitalized or out-patients referred to one of the participating centers for upper gastrointestinal endoscopy
  • Who did not received a previous eradication treatment
  • Willing to participate and signed inform consent. Finally only patients with bacteriologically documented H. pylori infection (PCR) will be included.

Exclusion Criteria:

  • Patient having already been treated to eradicate H pylori
  • No affiliation to social insurance
  • Person under legal protection
  • Refusal for signing informed consent
  • Patient included in another trial with medication
  • Patient unable to take oral medication ongoing
  • Patient with severe life-threatening disease in the short term
  • Contraindication to the PPIs, amoxicillin, metronidazole, clarithromycin, levofloxacin, tetracyclin or bismuth
  • Patient under treatment with antibiotics or PPI without possibility of interruption for 4 weeks
  • Pregnant or breast-feeding woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576236


Locations
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France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Dalila Selmane, CRA    (0)1 49 81 33 86 ext +33    dalila.selmane@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Charles Delchier, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02576236     History of Changes
Other Study ID Numbers: P140928
2015-A00457-42 ( Other Identifier: IDRCB )
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Naïve patient
Suspicion of H pylori infection
Endoscopy
Antibiotics therapeutic strategies
Urea breath test

Additional relevant MeSH terms:
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Clarithromycin
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Esomeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors