NCT06579365: ArgReg-Hp

Argentinean Registry on the Management of Helicobacter Pylori Infection

Recruiting now Last updated 30 August 2024

What this trial tests

trial in H.Pylori Gastrointestinal Disease in 5,000 participants. Currently enrolling.

Timeline

17 May 2021

Primary endpoint
1 January 2030

1 January 2034

Quick facts

Lead sponsor	University of Buenos Aires
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	17 May 2021
Primary completion	1 January 2030
Estimated completion	1 January 2034
Sites	1 location across Argentina

Conditions studied

• H.Pylori Gastrointestinal Disease — all drugs for H.Pylori Gastrointestinal Disease →
• H Pylori Infection — all drugs for H Pylori Infection →

Sponsor

University of Buenos Aires

Who can join

18 and older, any sex, with H.Pylori Gastrointestinal Disease or H Pylori Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.