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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

Tracking Information
First Submitted Date  ICMJE September 30, 2015
First Posted Date  ICMJE October 15, 2015
Last Update Posted Date July 5, 2017
Actual Study Start Date  ICMJE May 2016
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
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 (sequential treatment, control group) and 1/patients allocated to sequential treatment chosen according to the results of molecular detection of resistance (molecular test group) in the one hand, and 2/ patients allocated to quadruple bismuth therapy.
Change History Complete list of historical versions of study NCT02576236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
Safety criteria will include all adverse events occurring in the two treatment groups [ Time Frame: at 34 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • Eradication rates with 95% confidence intervals (CI) among patients allocated to empirical sequential treatment and those allocated to quadruple bismuth therapy [ Time Frame: at 34 month ]
  • Detection of H. pylori resistance to clarithromycin by PCR [ Time Frame: at 34 month ]
  • Safety criteria will include all adverse events occurring in the three treatment groups [ Time Frame: at 34 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Trial Comparing Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance vs Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • H Pylori Infection Eradication
  • Antibiotics Therapeutic Strategies
  • H Pylori Eradication
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Triple therapy guided by the result of the molecular resistance test
  • 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
    Intervention: Other: Quadruple concomitant therapy treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 21, 2016)
2500
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2015)
950
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02576236
Other Study ID Numbers  ICMJE P140928
2015-A00457-42 ( Other Identifier: IDRCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Charles Delchier, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP