Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

European Registry on the Management of Helicobacter Pylori Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328131
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Javier P. Gisbert, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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.


Condition or disease
H. Pylori Infection

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: European Registry on the Management of Helicobacter Pylori Infection
Study Start Date : June 2013
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prescribed treatment for H. pylori [ Time Frame: 1 year ]
    • Drugs
    • Dosage and intakes
    • Length of treatment


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 year ]
    • Type, intensity, duration and relation with treatment
    • Treatment withdrawal due to adverse event

  2. Efficacy [ Time Frame: 1 year ]
    Eradication (yes/no), test used and date

  3. Anonymised patient identifiers [ Time Frame: 1 year ]
    • Country/Centre/Investigator
    • Autonumeric Patient identifier number
    • Gender
    • Date of Birth
    • Ethnic Background



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infected adult patients by Helicobacter pylori
Criteria

Inclusion Criteria:

  • Infected adult patients by Helicobacter pylori

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328131


Contacts
Layout table for location contacts
Contact: Javier Pérez Gisbert, MD +34 913093911 javier.p.gisbert@gmail.com

  Show 30 Study Locations
Sponsors and Collaborators
Javier P. Gisbert
Investigators
Layout table for investigator information
Principal Investigator: Javier Pérez Gisbert, MD Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Javier P. Gisbert, Javier P. Gisbert MD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT02328131     History of Changes
Other Study ID Numbers: Hp-EuReg
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases