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European Registry on the Management of Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT02328131
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Javier P. Gisbert, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Tracking Information
First Submitted Date December 19, 2014
First Posted Date December 31, 2014
Last Update Posted Date July 28, 2020
Study Start Date June 2013
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 26, 2014)
Prescribed treatment for H. pylori [ Time Frame: 1 year ]
  • Drugs
  • Dosage and intakes
  • Length of treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 26, 2014)
  • Adverse Events [ Time Frame: 1 year ]
    • Type, intensity, duration and relation with treatment
    • Treatment withdrawal due to adverse event
  • Efficacy [ Time Frame: 1 year ]
    Eradication (yes/no), test used and date
  • Anonymised patient identifiers [ Time Frame: 1 year ]
    • Country/Centre/Investigator
    • Autonumeric Patient identifier number
    • Gender
    • Date of Birth
    • Ethnic Background
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title European Registry on the Management of Helicobacter Pylori Infection
Official Title European Registry on the Management of Helicobacter Pylori Infection
Brief Summary

The great diversity of regimens and treatment lines, the different efficacy of these, mostly due to the increase in bacterial antibiotic resistance and regional differences, requires a continuous critical analysis of clinical practice, evaluating systematically the efficacy and safety of the different regimens and the cost-effectiveness of the different diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized treatment that will reduce number of re-treatments, diagnostic tests and the appearance of associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably, gastric cancers. Therefore, the evaluation of real clinical practice using non-interventionist registries will help to improve the design and organization of European Consensus on the management of H. pylori infection, which is the best way to establish healthcare efficiency.

Primary aim

To obtain a database registering systematically over a year a large and representative sample of routine clinical practice of European gastroenterologists in order to produce descriptive studies of the management of H. pylori infection.

Secondary aims

  1. To evaluate H. pylori infection consensus and clinical guidelines implementation in different countries.
  2. To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori.
  3. To evaluate accessibility to healthcare technologies and drugs used in the management of H. pylori infection.
  4. To allow the development of partial and specific analysis by the participating researchers after approval by the Registry's Scientific Committee

Methodology Non-interventionist prospective multicentre international registry promoted by the European Helicobacter Study Group. A renowned gastroenterologist from each country was selected as Local Coordinator (30 countries). They will in turn select up to ten gastroenterologists per country that will register the routine clinical practice consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome data. The database will allow researchers to perform specific subanalysis after approval by the Scientific Committee of the study.

Detailed Description

Abstract

Introduction: H. pylori selectively infects the human stomach mucosa, being the most prevalent chronic infection in the world. Its prevalence correlates with socioeconomic factors and it is higher in older individuals. H. pylori presence causes chronic gastritis in 100% of infected patients and is the major cause of relevant diseases such as atrophic gastritis, peptic ulcer disease and gastric cancer; it is for this reason that from a public health standpoint it is considered a high impact pathogen, responsible of a significant morbidity and mortality. Nowadays there are Consensus and Clinical Guidelines regarding the infection management at a European level and in most of the states, but no data have shown the level of implementation of these recommendations. The high costs that this infection carries both socially and to the health system require the continuous and systematic assessment of the diagnostic and treatment strategies, as well as the accessibility to diagnostic methods and most efficient drugs.

Aim: To register the treatment, diagnosis and management strategies of H. pylori infected adult patients in the Digestive Services outpatient clinics throughout Europe.

Methods: Non-interventionist prospective multicentre international registry promoted by the European Helicobacter Study Group. A renowned gastroenterologist from each country was selected as Local Coordinator (30 countries). They will in turn select up to ten gastroenterologists per country that will register the routine clinical practice consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome data. The database will allow researchers to perform specific subanalysis after approval by the Scientific Committee of the study.

INTRODUCTION

H. pylori presence causes chronic gastritis in 100% of infected patients and is the major cause of relevant diseases such as atrophic gastritis, peptic ulcer disease and gastric cancer. H. pylori eradication prevents peptic ulcer recurrence and its complications, and decreases the incidence of gastric cancer. H. pylori eradication in patients with peptic ulcer or even functional or non-investigated dyspepsia is a cost-effective strategy.

The most common clinical manifestation of H. pylori infection is dyspepsia, a major health problem, whose prevalence reaches more than 10% among adult populations with its attendant burden of morbidity and health system costs in diagnosis and treatment. Approximately 20% to 30% of people in the community each year report chronic or recurrent dyspeptic symptoms, and consultations for dyspepsia account for up to 40% of referrals among gastroenterology outpatients, the "test-and-treat" strategy being the most cost-effective. Moreover, H. pylori is the major cause of peptic ulcer disease, causing over 90% of duodenal and 70% of gastric ulcers. Considerable evidence supports that the nature of the chronic inflammatory process driven by H. pylori is of critical importance in gastric carcinogenesis (adenocarcinoma and mucosa-associated lymphoid tissue -MALT- lymphoma). It is for that reason that the WHO's International Agency for Research on Cancer classified H. pylori as a group 1 (definite) carcinogen.

Scientific evidence demonstrates that diagnosis and eradication of H. pylori is the most cost-effective strategy in the management of dyspepsia, peptic ulcer and gastric cancer prevention. The treatment regimens are very diverse and have changed overtime. Monotherapies and treatments with two drugs did not achieve acceptable eradication rates. The commonly recommended regimen in most Consensus Conferences is the standard triple regimen, combining two antibiotics (clarithromycin with amoxicillin or metronidazole) and a proton pump inhibitor (PPI) for 7 to 14 days. Another recommended alternative is bismuth-containing quadruple therapy (PPI, tetracycline, metronidazole and bismuth salts). In the last years, results with new and efficient rescue regimens including levofloxacin have been published. Lately, new treatments have been proposed, including non-bismuth quadruple regimens, with two main variants: the "sequential" treatment (an induction phase with PPI and amoxicillin and a second phase with PPI, clarithromycin and metronidazole) and the "concomitant" treatment (same four drugs taken altogether).

The great diversity of regimens and treatment lines, the different efficacy of these, mostly due to the increase in bacterial antibiotic resistance and regional differences, requires a continuous critical analysis of clinical practice, evaluating systematically the efficacy and safety of the different regimens and the cost-effectiveness of the different diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized treatment that will reduce number of re-treatments, diagnostic tests and the appearance of associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably, gastric cancers. Therefore, the evaluation of real clinical practice using non-interventionist registries will help to improve the design and organization of European Consensus on the management of H. pylori infection, which is the best way to establish healthcare efficiency.

AIMS

Primary aim To obtain a database registering systematically over a year a large and representative sample of routine clinical practice of European gastroenterologists in order to produce descriptive studies of the management of H. pylori infection.

Secondary aims

  1. To evaluate H. pylori infection consensus and clinical guidelines implementation in different countries.
  2. To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori.
  3. To evaluate accessibility to healthcare technologies and drugs used in the management of H. pylori infection.
  4. To allow the development of partial and specific analysis by the participating researchers after approval by the Registry's Scientific Committee.

METHODS

International multicenter prospective non-interventionist registry promoted by the European Helicobacter Study Group.

Scientific Committee

  • Javier P. Gisbert (President)
  • Francis Megraud
  • Colm O'Morain
  • Adrian G. McNicholl

Local Coordinators

A list of European Countries has been selected. Included countries were those having at least ten clinical research publications in PubMed regarding H. pylori infection.

In each country a Local Coordinator was selected based on its clinical and research activity (Table I).

The Local Coordinators will constitute the monitoring and drafting committee of the registry.

The Local Coordinators will be in charge of selecting up to 10 recruiting investigators in each country and will be in charge of the follow up and quality of the recruiting; they will be the link between promoters and recruiting investigators.

Recruiter Investigators

The Recruiting Investigators must be gastroenterologists attending an adult population with a gastroenterology outpatient clinic that assists H. pylori infected patients. Before acceptance the outpatient clinic must attend, in a clinical routine basis, patients in which H. pylori diagnosis or treatment is indicated. Eradication confirmation tests have to be performed routinely. They will register the study variables of their own routine clinical practice in an e-CRF.

Study Variables

Anonymised Patient Identifiers

  • Country/Centre/Investigator
  • Autonumeric Patient identifier number
  • Gender
  • Date of Birth
  • Ethnic Background History and Comorbidity
  • Drug allergies
  • Relevant comorbidities
  • Current concomitant medication Data on Infection
  • Indication for diagnosis and treatment
  • Upper Gastrointestinal tract symptoms
  • Diagnostic Test for current treatment
  • Number and type of previous eradication attempts Prescribed Treatment
  • Drugs
  • Dosage and intakes per day
  • Length of treatment Compliance
  • Adherence to treatment (yes/no >90%) Adverse Events
  • Type of event, intensity, duration and relation with treatment
  • Treatment withdrawal due to adverse events. Efficacy
  • Eradication (yes/no), test used, and date
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infected adult patients by Helicobacter pylori
Condition H. Pylori Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 10, 2015)
10000
Original Actual Enrollment
 (submitted: December 26, 2014)
6416
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Infected adult patients by Helicobacter pylori

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Javier Pérez Gisbert, MD +34 913093911 javier.p.gisbert@gmail.com
Listed Location Countries Austria,   Belgium,   Bulgaria,   Croatia,   Czechia,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Latvia,   Lithuania,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovenia,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT02328131
Other Study ID Numbers Hp-EuReg
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Javier P. Gisbert, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Sponsor Javier P. Gisbert
Collaborators Not Provided
Investigators
Principal Investigator: Javier Pérez Gisbert, MD Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
PRS Account Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Verification Date July 2020