Helicobacter Pylori InfectionHELICOSTICNCT01168063
Molecular Detection of Antibiotic Resistance and H Pylori Eradication
A study testing Molecular detection of antibiotic resistance and standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole) in people with Helicobacter Pylori Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
H pylori eradication failure with recommended triple therapy is mainly related to antibiotic resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine practice. A molecular test of antibiotic resistance easy to perform is now available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Molecular detection of antibiotic resistance and standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,386 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Mar 2013
- 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
- H pylori infection bacteriologically confirmed
- Age > 18 years
- Naïve patient or one failure of the first line recommended treatment
- Patient referred to one out of the centres participating in the study
Who cannot join
- H pylori positive patient with at least failure of two lies of treatment
- patients with previous adverse event with PPI, amoxicillin, clarithromycin, levofloxacin or metronidazole
- PPI or antibiotic treatment in progressor stopped for less than 4 weeks
- patient with other severe sickness
Trial locations and contacts
1 site in 1 country.
About this study
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 failure with recommended triple therapy is mainly related to antibiotic resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine practice. A molecular test of antibiotic resistance easy to perform is now available. The aim of the study was to compare eradication rates obtained with the standard treatment and with a treatment guided by the results of the molecular detection of antibiotic resistance.
Read the detailed description
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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Molecular detection of antibiotic resistance, standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)
- Keywords
- Helicobacter pylori, Diagnostic molecular testing, Antibiotic resistance, Treatment protocols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular detection of antibiotic resistanceDrug
Also called Helicobacter Molecular detection of resistance to clarithromycin and quinolones, Use of triple therapy base on antibiotics resistances (PPI,amoxicillin,clarithromycin, metronidazole)
Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole)
standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)Drug
Also called Standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole ….)
2 lines of treatments :
- PPI + Amoxicillin + Clarithromycin for 7 days
- PPI + Amoxicillin + Metronidazole for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Helicobacter pilory triple treatment | Experimental | Triple treatment on this arm is based on results of molecular detection of resistance to antibiotics Receives: Drug: Molecular detection of antibiotic resistance |
| Helicobacter pilori standard recommended treatment | Active comparator | H.Pylori Eradication rate with empirical treatment Receives: Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate (at 3months according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance)
at 3 months according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance
Measured: at 3 months
Secondary outcomes (1)
Comparative cost of the two strategies
Measured: at 6 months according to the two strategies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies 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
- 1,386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Delchier, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168063
- Sponsor's protocol ID
- P090210
- Acronym
- HELICOSTIC
- Status last verified
- Nov 2013
- First submitted
- 21 Jul 2010
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Breuer T, Graham DY. Costs of diagnosis and treatment of Helicobacter pylori infection: when does choosing the treatment regimen based on susceptibility testing become cost effective? Am J Gastroenterol. 1999 Mar;94(3):725-9. doi: 10.1111/j.1572-0241.1999.00943.x.
PubMed 10086658Delchier JC, Bastuji-Garin S, Raymond J, Megraud F, Amiot A, Cambau E, Burucoa C; HELICOSTIC Study Group. Efficacy of a tailored PCR-guided triple therapy in the treatment of Helicobacter pylori infection. Med Mal Infect. 2020 Sep;50(6):492-499. doi: 10.1016/j.medmal.2019.06.001. Epub 2019 Jun 27.
PubMed 31257067
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of a Therapeutic Strategy Based on Molecular Detection of Antibiotic Resistance in the Management of H Pylori Infection
- ClinicalTrials.gov ID
- NCT01168063
- Acronym / sponsor ID
- HELICOSTIC / P090210
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Diagnostic molecular testing, Antibiotic resistance, Treatment protocols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,386 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Jul 2010 (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.
H pylori eradication failure with recommended triple therapy is mainly related to antibiotic resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine practice. A molecular test of antibiotic resistance easy to perform is now available. The aim of the study was to compare eradication rates obtained with the standard treatment and with a treatment guided by the results of the molecular detection of antibiotic resistance.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helicobacter pilory triple treatment | Experimental | Drug: Molecular detection of antibiotic resistanceTriple treatment on this arm is based on results of molecular detection of resistance to antibiotics |
| Helicobacter pilori standard recommended treatment | Active comparator | Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)H.Pylori Eradication rate with empirical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- H pylori infection bacteriologically confirmed
- Age > 18 years
- Naïve patient or one failure of the first line recommended treatment
- Patient referred to one out of the centres participating in the study
Key exclusion criteria (4 listed)
- H pylori positive patient with at least failure of two lies of treatment
- patients with previous adverse event with PPI, amoxicillin, clarithromycin, levofloxacin or metronidazole
- PPI or antibiotic treatment in progressor stopped for less than 4 weeks
- patient with other severe sickness
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 |
|---|---|---|
| Molecular detection of antibiotic resistanceAlso: Helicobacter Molecular detection of resistance to clarithromycin and quinolones, Use of triple therapy base on antibiotics resistances (PPI,amoxicillin,clarithromycin, metronidazole)Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole) | Drug | Helicobacter pilory triple treatment |
| standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)Also: 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 | Drug | Helicobacter pilori standard recommended treatment |
Primary outcome
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
1 secondary outcome
Comparative cost of the two strategies
Time frame: at 6 months according to the two strategies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Results publication: PubMed 10086658Breuer T, Graham DY. Costs of diagnosis and treatment of Helicobacter pylori infection: when does choosing the treatment regimen based on susceptibility testing become cost effective? Am J Gastroenterol. 1999 Mar;94(3):725-9. doi: 10.1111/j.1572-0241.1999.00943.x.
- Derived from this study: PubMed 31257067Delchier JC, Bastuji-Garin S, Raymond J, Megraud F, Amiot A, Cambau E, Burucoa C; HELICOSTIC Study Group. Efficacy of a tailored PCR-guided triple therapy in the treatment of Helicobacter pylori infection. Med Mal Infect. 2020 Sep;50(6):492-499. doi: 10.1016/j.medmal.2019.06.001. Epub 2019 Jun 27.
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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, PU-PH 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 Molecular detection of antibiotic resistance and standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole) in people with Helicobacter Pylori Infection, 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 4 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: finished, as of the sponsor's last update on 8 Nov 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT01168063, which also lists 2 linked publications.
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 8 Nov 2013.