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Argentinean Registry on the Management of Helicobacter Pylori Infection

NCT06579365 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2024-08-30

No results posted yet for this study

Summary

Helicobacter pylori (H pylori) is the main cause of chronic gastritis and peptic ulcer disease. In addition, is the main risk factor for gastric adenocarcinoma and mucosa-associated lymphoid tissue lymphoma. It is estimated that around 50% of the Argentinean population is infected with H pylori. The optimal management of H pylori remains unclear. In Argentina, most treatments are prescribed on an empiric basis, unaware of the bacterial antibiotic resistance profile.

Meta-analysis showed that susceptibility-guided treatment is not better than empirical treatment in first and second line treatment therapy if the most effective local regimens are prescribed. Updated information concerning local data is needed to design the best strategy to treat H pylori infection in order to reach high eradication rates and to introduce the principles of antimicrobial stewardship to reduce inappropriate antibiotic use.

The Argentinean Registry on H pylori (ArgReg-Hp) management was launched in May 2021 in order to obtain a large and representative sample of routine clinical practice of Argentinean gastroenterologist. Its main focus was to identify therapies that are highly effective and can be used empirically. Test of cure data is a surrogate method for susceptibility testing and resistance Primary aim To obtain a database registering systematically of a large and representative sample of routine clinical practice of Argentinean gastroenterologists in order to produce descriptive studies of the management of H. pylori infection.

Secondary aims To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori.

The Argentinean Registry on H pylori management is a National , multicenter, prospective, non interventional registry recording data on H pylori management since May 2021. The ArgReg-Hp is promoted by Instituto de Investigaciones Médicas Alfredo Lanari (IDIM), Universidad de Buenos Aires and Club Argentino Estómago y duodeno (CADED).

Ethics: ArgReg-Hp was approved by the Ethics Committee IDIM, University of Buenos Aires as the reference IRB, and was approved by each center participant

Conditions

  • H.Pylori Gastrointestinal Disease
  • H Pylori Infection

Sponsors & Collaborators

  • University of Buenos Aires

    lead OTHER

Principal Investigators

  • Oscar M Laudanno, MD · Instituto de Investigaciones Médicas Alfredo Lanari. Universidad de Buenos Aires

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2030-01-01
Completion
2034-01-01

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579365 on ClinicalTrials.gov