NCT01168063

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,386

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

2.1 years

First QC Date

July 21, 2010

Last Update Submit

November 7, 2013

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriDiagnostic molecular testingAntibiotic resistanceTreatment protocols

Outcome Measures

Primary Outcomes (1)

  • 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

    at 3 months

Secondary Outcomes (1)

  • Comparative cost of the two strategies

    at 6 months according to the two strategies

Study Arms (2)

Helicobacter pilory triple treatment

EXPERIMENTAL

Triple treatment on this arm is based on results of molecular detection of resistance to antibiotics

Drug: Molecular detection of antibiotic resistance

Helicobacter pilori standard recommended treatment

ACTIVE COMPARATOR

H.Pylori Eradication rate with empirical treatment

Drug: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)

Interventions

Molecular detection of antibiotic resistanceDRUG

Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole)

Also known as: Helicobacter Molecular detection of resistance to clarithromycin and quinolones, Use of triple therapy base on antibiotics resistances (PPI,amoxicillin,clarithromycin, metronidazole)
Helicobacter pilory triple treatment
standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)DRUG

2 lines of treatments : 1\) PPI + Amoxicillin + Clarithromycin for 7 days 1\) PPI + Amoxicillin + Metronidazole for 14 days

Also known as: Standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole ….)
Helicobacter pilori standard recommended treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

Related Publications (2)

  • 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.

    PMID: 10086658RESULT

  • Delchier 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.

    PMID: 31257067DERIVED

MeSH Terms

Interventions

QuinolonesClarithromycinMetronidazoleAmoxicillin

Intervention Hierarchy (Ancestors)

QuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesSulfur Compounds

Study Officials

  • Jean-Charles Delchier, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 22, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

FR(1)