Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03361267
Status:
UNKNOWN
Last Update Posted:
2017-12-12
First Post:
2017-11-28
Brief Title:
Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H Pylori Infection
Sponsor:
Inha University Hospital
Organization:
Inha University Hospital
Study Overview
Official Title:
Comparison of Bismuth Containing Quadruple Therapy and Clarithromycin Susceptibility-based Tailored Therapy for Helicobacter Pylori First-line Eradication
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
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:
As the antibiotic resistance increases the eradication rate of triple therapy is decreasing Recent guideline recommend the use of bismuth-containing quadruple therapy in areas where clarithromycin resistance is greater than 15 However the ideal treatment would be the tailored therapy which choose the antibiotics depending on the antibiotic resistance This study compared the eradication rates safety and complicance of tailored therapy compared with empirical bismuth quadruple therapy in the naive patients with H pylori infection
Detailed Description:
In order to be eligible for first-line H pylori eradication therapy at least 80 of eradication rate should be achieved by intention to treat ITT analysis However the triple therapy PPI clarithromycin amoxicillin is losing 1st-line therapy because of increasing antibiotic resistance The most common cause of failure in triple therapy is clarithromycin resistance
In the past clarithromycin resistance was rarely observed in Korea but the resistance rate has increased rapidly during the last 10 years up to 373
As an alternative Korean guidelines of Helicobacter pylori eradication in 2013 recommend that bismuth-containing antibiotics not containing clarithromycin should be considered in areas with high clarithromycin resistance as in Korea However there is a lack of research on the efficacy of bismuth-containing quadruple therapy as a 1st-line therapy The aim of this prospectivce randomized study is to investingate the efficacy conpliance adverse events and cost-effectiveness between bismuth containing quadruple therapy and tailored therapy in areas with high clarithromycin resistance
In the past clarithromycin resistance was rarely observed in Korea but the resistance rate has increased rapidly during the last 10 years up to 373
As an alternative Korean guidelines of Helicobacter pylori eradication in 2013 recommend that bismuth-containing antibiotics not containing clarithromycin should be considered in areas with high clarithromycin resistance as in Korea However there is a lack of research on the efficacy of bismuth-containing quadruple therapy as a 1st-line therapy The aim of this prospectivce randomized study is to investingate the efficacy conpliance adverse events and cost-effectiveness between bismuth containing quadruple therapy and tailored therapy in areas with high clarithromycin resistance
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