Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652284
Status:
UNKNOWN
Last Update Posted:
2021-03-10
First Post:
2020-11-01
Brief Title:
Effectiveness of Rifabutin for Treatment of Helicobacter Pylori
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Effectiveness of Rifabutin Triple Therapy for First-line and Rescue Treatment of Helicobacter Pylori Infection
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
The aim of this study is to determine the effectiveness of rifabutin triple therapy for the treatment of H pylori infection in the Israeli population Patients with or without a prior history of H pylori eradication failure will be randomized to receive one of three possible treatments
Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care
Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care
Detailed Description:
Patients who present to the outpatient gastroenterology clinic at our institution with a positive diagnostic test for H pylori will be screened Included patients will undergo randomisation into 3 groups Randomization will be performed by a random sequence generator to create equal sized groups in boxes of 12
Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care Standard of care in previously untreated patients will consist of concomitant treatment amoxicillin 1000mg clarithromycin 500 mg tinidazole 500 mg and esomeprazole all given twice daily for 14 days In previously treated patients standard of care will consist of bismuth quadruple therapy quinolone based therapy or other susceptibility guided treatment where available
Treatment duration will be 14 days in all groups Patients who are randomised to Group 3 and fail treatment will be offered open label rescue treatment with amoxicillin 1000mg bd rifabutin 150 mg bd and esomeprazole 40 mg bd 14 days
Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care Standard of care in previously untreated patients will consist of concomitant treatment amoxicillin 1000mg clarithromycin 500 mg tinidazole 500 mg and esomeprazole all given twice daily for 14 days In previously treated patients standard of care will consist of bismuth quadruple therapy quinolone based therapy or other susceptibility guided treatment where available
Treatment duration will be 14 days in all groups Patients who are randomised to Group 3 and fail treatment will be offered open label rescue treatment with amoxicillin 1000mg bd rifabutin 150 mg bd and esomeprazole 40 mg bd 14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None