Clinical trial NCT02328131: European Registry on the Management of Helicobacter Pylori Infection
Official title: European Registry on the Management of Helicobacter Pylori Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: H. Pylori Infection
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infected adult patients by Helicobacter pylori

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

Eligibility criteria: Inclusion Criteria:

* Infected adult patients by Helicobacter pylori

Exclusion Criteria:

Primary outcomes:
measure: Prescribed treatment for H. pylori
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 year
measure: Efficacy of treatment
timeFrame: 1 year
measure: Anonymised patient identifiers
timeFrame: 1 year
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medical University Wien
city: Charleroi
country: Belgium
facility: CHU de Charleroi, Charleroi
city: Sofia
country: Bulgaria
facility: Medical University of Sofia
city: Zagreb
country: Croatia
facility: University Hospital Merkur
city: Prague
country: Czechia
facility: Charles University Faculty of Medicine
city: Køge
country: Denmark
facility: Køge University Hospital
city: Tartu
country: Estonia
facility: University of Tartu
city: Helsinki
country: Finland
facility: Herttoniemi Hospital, Helsinki
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Magdeburg
country: Germany
facility: Medizin Uni Magdeburg
city: Athens
country: Greece
facility: Gastroenterology Clinic, Henry Dunant Hospital
city: Budapest
country: Hungary
facility: Ferencváros Health Centre, Gaastroenterology
city: Dublin
country: Ireland
facility: Adelaide Meath Hospital, Dublin
city: Roma
country: Italy
facility: Studio Gasbarrini
city: Riga
country: Latvia
facility: Digestive Diseases Centre GASTRO
city: Kaunas
country: Lithuania
facility: Lithuanian university of Health Sciences Hospital
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis/ Erasmus Medisch Centrum
city: Fredrikstad
country: Norway
facility: Central Hospital of Ostfold
city: Warsaw
country: Poland
facility: Departament of Gastroenterology, Medical Centre for Postgraduate Education
city: Porto
country: Portugal
facility: Porto
city: Timisoara
country: Romania
facility: Timisoara
city: Moscow
country: Russian Federation
facility: Central Scientific Research Institute of Gastroenterology
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Rogaska Slatina
country: Slovenia
facility: DC Rogaska
city: Madrid
country: Spain
facility: Hospital de La Princesa, Madrid
city: Uppsala
country: Sweden
facility: Uppsala University Hospital.
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Izmir
country: Turkey
facility: Dokuz Eylul University School of Medicine
city: Kiev
country: Ukraine
facility: National Medical University
city: Leeds
country: United Kingdom
facility: Leeds General Infirmiry Hospital
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Javier Pérez Gisbert, MD
role: PRINCIPAL_INVESTIGATOR
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