Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04147065
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2019-10-20
Brief Title:
Helicobacter Pylori Eradication According to DPO-PCR Methods K-CREATE Study
Sponsor:
Incheon StMarys Hospital
Organization:
Incheon StMarys Hospital
Study Overview
Official Title:
Helicobacter Pylori Eradication According to DPO-PCR Methods Duration of Triple Therapy and Bismuth Quadruple According to Clarithromycin Resistance Patterns K-CREATE Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government However studies of antibiotic resistance have shown that regional resistance patterns to antibiotics such as clarithromycin are increasing Recent studies show that examining genotype resistance is effective in eradication Currently dual priming oligonucleotide-polymerase chain reaction DPO-PCR is used to measure clarithromycin resistance No study has compared the duration of eradication regimens according to DPO-PCR results This study compares the eradication rate of 7-day triple therapy with 14-day triple therapy in clarithromycin susceptible strains from DPO-PCR The investigators also aimed to compare the eradication rates of 7-day bismuth quadruple therapy with 14-day bismuth quadruple therapy from clarithromycin-resistant strains from DPO-PCR
Detailed Description:
This is a multi-center study performed at 20 university hospitals The study is composed of two phases In phase I patients with H pylori infection are randomized to receive tailored or empirical therapy The empirical therapy group is further randomized to receive either 7-day triple therapy or 14-day triple therapy The tailored group is randomized to receive triple therapy if they are clarithromycin sensitive or bismuth quadruple therapy if they are clarithromycin resistant Each group is further randomized to receive either seven or 14 days of treatment The eradication rates and adverse events of each regimen will be investigated
In phase 2 patients with H pylori infection are randomized to receive tailored or empirial therapy The empirical therapy group receives 14 days of triple therapy The tailored therapy group receives 7-day triple therapy if they are clarithromycin sensitive and 7-day bismuth quadruple therapy if clarithromycin resistant
In phase 2 patients with H pylori infection are randomized to receive tailored or empirial therapy The empirical therapy group receives 14 days of triple therapy The tailored therapy group receives 7-day triple therapy if they are clarithromycin sensitive and 7-day bismuth quadruple therapy if clarithromycin resistant
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