Argentinean Registry on the Management of Helicobacter Pylori Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Buenos Aires
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Infected adult patients by Helicobacter pylori
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Effectiveness of H pylori eradication regimens in the real world
Eradication (yes or No). Negative Urea Breath Test or stool antigen
Time frame
At least 4-6 weeks after the treatmentSecondary outcomes
1
Diagnostic methods for H pylori detection and eradication
Test used
Time frame
90 days2
Frecuency of adverse events
Any possible adverse events during the treatment period. Treatment withdrawal due to adverse events
Time frame
90 days3
Effectiveness of the different H pylori treatments according to BMI
BMI
Time frame
90 days4
Compliance rate
Compliance was defined as good when subjects had taken more than 90% of the total medication
Time frame
90 daysLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Instituto de Investigaciones Medicas Alfredo Lanari. Universidad de Buenos AiresRecruiting1427, Ciudad de Buenos Aires
Argentina
ArgentinaSponsors and contacts
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Source ClinicalTrials.gov