Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05635942
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2022-11-10
Brief Title:
Optimized-dose Amoxicillin Versus Standard-dose Amoxicillin for Quadruple Therapy in Helicobacter Pylori Eradication
Sponsor:
Les Laboratoires des Médicaments Stériles
Organization:
Les Laboratoires des Médicaments Stériles
Study Overview
Official Title:
Prospective Randomized Trial Comparison Between Optimized-dose Amoxicillin and Standard-dose Amoxicillin for Quadruple Therapy in the Treatment of Helicobacter Pylori Infection in Tunisian Patients
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Helicomatri
Brief Summary:
The goal of this prospective randomized clinical trial is to compare the rate of Helicobacter Pylori HP eradication after standard or dose-optimized amoxicillin quadritherapy in patients naïve to any anti-HP treatment and with chronic HP infection documented by histological examination The main questions it aims to answer are
compare the eradication rate of HPylori after a standard concomitant quadritherapy with 2g of amoxicillin versus an optimized quadritherapy with 3g of amoxicillin in Tunisian population
Identify different factors associated with poor therapeutic response Patients were randomly assigned to either standard quadruple therapy Qs-14 amoxicillin 1g twice daily clarithromycin 500mg twice daily metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days or optimized quadruple therapy Qo-14 amoxicillin 1g three times a day clarithromycin 500mg twice daily metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days Eradication control was performed by urea breath test
compare the eradication rate of HPylori after a standard concomitant quadritherapy with 2g of amoxicillin versus an optimized quadritherapy with 3g of amoxicillin in Tunisian population
Identify different factors associated with poor therapeutic response Patients were randomly assigned to either standard quadruple therapy Qs-14 amoxicillin 1g twice daily clarithromycin 500mg twice daily metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days or optimized quadruple therapy Qo-14 amoxicillin 1g three times a day clarithromycin 500mg twice daily metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days Eradication control was performed by urea breath test
Detailed Description:
This study was a prospective randomized single-center study conducted in the hepato-gastroenterology department of Mahmoud Matri Hospital in Ariana in collaboration with the bacteriology and biochemistry laboratory of the same hospital the anatomopathology department of Abderrahmen Mami Hospital in Ariana and the private clinical analysis laboratory Fendri all patients aged from 18 and 65 years-old with H pylori infection documented by pathological examination of per endoscopic gastric biopsies were recruited
This was a population of patients who had undergone upper endoscopy UE and in whom the search for HPylori was indicated according to the European Maastrich IV recommendations
Eligible subjects were randomly assigned in a 11 ratio to receive either standard quadruple therapy Qs-14 including amoxicillin 1g twice daily clarithromycin 500mg twice daily metronidazole 500mg twice daily and esomeprazole Medis Pharmaceutical Company 40 mg twice daily for 14 days or optimized quadruple therapy Qo-14 including amoxicillin 1g three times daily clarithromycin 500mg twice daily metronidazole 500mg twice daily and esomeprazole 40 mg twice daily Medis Pharmaceutical Company for 14 days
Eradication control was performed by 13C-UBT at least 4 weeks after the end of the treatment
This was a population of patients who had undergone upper endoscopy UE and in whom the search for HPylori was indicated according to the European Maastrich IV recommendations
Eligible subjects were randomly assigned in a 11 ratio to receive either standard quadruple therapy Qs-14 including amoxicillin 1g twice daily clarithromycin 500mg twice daily metronidazole 500mg twice daily and esomeprazole Medis Pharmaceutical Company 40 mg twice daily for 14 days or optimized quadruple therapy Qo-14 including amoxicillin 1g three times daily clarithromycin 500mg twice daily metronidazole 500mg twice daily and esomeprazole 40 mg twice daily Medis Pharmaceutical Company for 14 days
Eradication control was performed by 13C-UBT at least 4 weeks after the end of the treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None