Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05152004
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-11-28
Brief Title:
Efficacies of Hybrid and High-dose Dual Therapies for the First-line Anti-H Pylori Treatment
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Efficacies of Hybrid and High-dose Dual Therapies for the First-line Anti-H Pylori Treatment - a Randomized Trial
Status:
COMPLETED
Status Verified Date:
2021-12
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:
None
Brief Summary:
Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains and have a great potential to replace bismuth quadruple therapy in the treatment of H pylori infection This study aims to better understand the potential of both hybrid and igh-dose dual therapies in the treatment of H pylori infection
Detailed Description:
Helicobacter pylori H pylori infect more than 50 of humans globally It is the principal cause of chronic gastritis gastric ulcer duodenal ulcer gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma MALToma The Real-world Practice Expectation of Asia-Pacific Physicians and Patients in H pylori Eradication REAP-HP Survey demonstrated that standard triple therapy was still the most commonly used anti-H pylori regimen in the Asia Pacific region However the eradication rates of standard triple therapy have declined to less than 80 in most countries worldwide The main reasons for eradication failure of standard triple therapy include antibiotic resistance poor compliance and CYP2C19 genotype of host Clarithromycin resistance of H pylori has been identified as the main reason for the failure of standard triple therapy Pooled data from 20 studies involving 1975 patients treated with standard triple therapy showed an eradication rate of 88 in clarithromycin-sensitive strains versus 18 in clarithromycin-resistant strains Therefore the background rate of clarithromycin resistance is critically important for the efficacy of standard triple therapy Recently several strategies including bismuth-containing quadruple therapy non-bismuth quadruple therapy ie sequential therapy concomitant therapy and hybrid therapy and high-dose dual therapy have been proposed to increase the eradication rate
Hybrid therapy developed by our study group in 2011 consists of a dual therapy with a proton pump inhibitor PPI and amoxicillin for 7 days followed by a quadruple regimen with a PPI amoxicillin clarithromycin and metronidazole for 7 days 10 It achieved an eradication rate of 974 by intention-to-treat ITT analysis and 991 by per-protocol PP analysis in a Taiwan population with clarithromycin resistance rate of 7 Subsequent randomized controlled trials demonstrated that 14-day hybrid therapies were comparable or more effective than 10-day sequential therapies A recent large multicentre randomized controlled trial documented that 14-day hybrid and 14-day concomitant therapies had comparable efficacy in the treatment of H pylori infection and both could cure more than 90 of patients with H pylori infections in areas of high clarithromycin and metronidazole resistance 24 Therefore hybrid therapy has a great potential to replace bismuth quadruple therapy in the first-line treatment of H pylori infection Currently hybrid therapy is a recommended first-line treatment for H pylori infection in the ACG guideline
Bangkok Consensus Report and Taiwan Consensus Report High-dose dual therapy developed by Yang et al is another emerging treatment for H pylori infection The new therapy consists of high-dose PPI and amoxicillin which keep the intragastric pH at a value higher than 65 regardless of CYP2C19 genotype and maintain steady plasma concentration of amoxicillin above the minimal inhibitory concentration MIC for H pylori 28 The efficacy of the new therapy was significantly higher than that of standard triple therapy in Taiwan However it was less effective as the first-line therapy for eradicating H pylori in Korea and in the United States
This study aims to better understand the potential of both hybrid and igh-dose dual therapies in the treatment of H pylori infection
Hybrid therapy developed by our study group in 2011 consists of a dual therapy with a proton pump inhibitor PPI and amoxicillin for 7 days followed by a quadruple regimen with a PPI amoxicillin clarithromycin and metronidazole for 7 days 10 It achieved an eradication rate of 974 by intention-to-treat ITT analysis and 991 by per-protocol PP analysis in a Taiwan population with clarithromycin resistance rate of 7 Subsequent randomized controlled trials demonstrated that 14-day hybrid therapies were comparable or more effective than 10-day sequential therapies A recent large multicentre randomized controlled trial documented that 14-day hybrid and 14-day concomitant therapies had comparable efficacy in the treatment of H pylori infection and both could cure more than 90 of patients with H pylori infections in areas of high clarithromycin and metronidazole resistance 24 Therefore hybrid therapy has a great potential to replace bismuth quadruple therapy in the first-line treatment of H pylori infection Currently hybrid therapy is a recommended first-line treatment for H pylori infection in the ACG guideline
Bangkok Consensus Report and Taiwan Consensus Report High-dose dual therapy developed by Yang et al is another emerging treatment for H pylori infection The new therapy consists of high-dose PPI and amoxicillin which keep the intragastric pH at a value higher than 65 regardless of CYP2C19 genotype and maintain steady plasma concentration of amoxicillin above the minimal inhibitory concentration MIC for H pylori 28 The efficacy of the new therapy was significantly higher than that of standard triple therapy in Taiwan However it was less effective as the first-line therapy for eradicating H pylori in Korea and in the United States
This study aims to better understand the potential of both hybrid and igh-dose dual therapies in the treatment of H pylori infection
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