Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579365
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Argentinean Registry on the Management of Helicobacter Pylori Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Argentinean Registry on the Management of Helicobacter Pylori Infection
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ArgReg-Hp
Brief 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
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
Detailed 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 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 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
ProvinceCentreInvestigator Gender Date of Birth Ethnic Background History and Comorbidity BMI 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 yesno 90 Probiotics use Adverse Events Type of event intensity duration and relation with treatment Treatment withdrawal due to adverse events Efficacy Eradication yesno test used and date
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 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
ProvinceCentreInvestigator Gender Date of Birth Ethnic Background History and Comorbidity BMI 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 yesno 90 Probiotics use Adverse Events Type of event intensity duration and relation with treatment Treatment withdrawal due to adverse events Efficacy Eradication yesno test used and date
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None