H Pylori Infection EradicationHepyséNCT02576236
Therapeutic Trial Comparing Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance vs Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection
A study testing Quadruple concomitant therapy treatment and Triple therapy guided by the result of the molecular resistance test in people with H Pylori Infection Eradication and Antibiotics Therapeutic Strategies, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- H Pylori Infection Eradication, Antibiotics Therapeutic Strategies, H Pylori Eradication
- What is being tested?
- Quadruple concomitant therapy treatment and Triple therapy guided by the result of the molecular resistance test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Henri Mondor Hospital
Créteil, 94010
Dalila Selmane, CRA, (0)1 49 81 33 86 ext. +33, dalila.selmane@aphp.fr
About this study
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
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.
Read more
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.
- Being tested
- Quadruple concomitant therapy treatment, Triple therapy guided by the result of the molecular resistance test
- Keywords
- Naïve patient, Suspicion of H pylori infection, Endoscopy, Antibiotics therapeutic strategies, Urea breath test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadruple concomitant therapy treatmentOther
Also called therapeutic procedure
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
Triple therapy guided by the result of the molecular resistance testOther
Also called therapeutic procedure
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.
| Study group | Role | What they receive |
|---|---|---|
| Triple therapy guided by result of the molecular resistance | Experimental | * 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. Receives: Other: Triple therapy guided by the result of the molecular resistance test |
| 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 Receives: Other: Quadruple concomitant therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 34 month
Secondary outcomes (1)
Safety criteria will include all adverse events occurring in the two treatment groups
Measured: at 34 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startMay 2016
- Primary completionFeb 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for H Pylori Infection EradicationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Delchier, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576236
- Sponsor's protocol ID
- P140928
- Other IDs
- 2015-A00457-42
- Acronym
- Hepysé
- Status last verified
- Jun 2017
- First submitted
- 30 Sep 2015
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38680067
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02576236
- Acronym / sponsor ID
- Hepysé / P140928
- Keywords
- Naïve patient, Suspicion of H pylori infection, Endoscopy, Antibiotics therapeutic strategies, Urea breath test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple therapy guided by result of the molecular resistance | Experimental | Other: 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. |
| Quadruple concomitant therapy | Active comparator | Other: Quadruple concomitant therapy treatmenthigh dose PPI (Esoméprazole 40 mg X 2 / d- amoxicillin 1gX2 / d - - clarithromycin 500mgX2 / d - metronidazole 500mgX2 / d for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadruple concomitant therapy treatmentAlso: therapeutic procedureQuadruple 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 | Quadruple concomitant therapy |
| Triple therapy guided by the result of the molecular resistance testAlso: therapeutic procedureTriple 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 | Triple therapy guided by result of the molecular resistance |
Primary outcome
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.
1 secondary outcome
Safety criteria will include all adverse events occurring in the two treatment groups
Time frame: at 34 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Derived from this study: PubMed 38680067Amiot 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles Delchier, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadruple concomitant therapy treatment and Triple therapy guided by the result of the molecular resistance test in people with H Pylori Infection Eradication and Antibiotics Therapeutic Strategies, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02576236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.