Ignite Creation Date:
2024-05-05 @ 10:08 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01032655
Status:
COMPLETED
Last Update Posted:
2012-06-26
First Post:
2009-12-14
Brief Title:
The Efficacy of Susceptibility Test -Driven Sequential Therapy as the Third Line Therapy for Refractory Helicobacter Pylori Infection
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Efficacy of Susceptibility Test -Driven Sequential Therapy as the Third Line Therapy for Refractory Helicobacter Pylori Infection
Status:
COMPLETED
Status Verified Date:
2012-06
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:
Background Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases Eradication of H pylori infection could reduce the occurence or recurrence of these diseases However it was estimated that 15-20 of patients would fail from first line standard eradication therapy and need second line rescue therapy About 15-30 of patient would fail from second line therapy and need to be rescued with third line therapy The commonly used salvage regimens include 1 Bismuth based quadruple therapy combined with ranitidine or PPI plus two antibiotics 2 Levofloxacin or moxifloxacin or rifabutin based triple therapy However Bismuth is not available in many countries and the administration method is complex Its usage is limited by the high pill number and low compliance rate In recent years the concept of sequential therapy has been advocated in the treatment of H pylori infection The regimen includes a PPI plus amoxicillin for five days followed by a PPI plus clarithromycin and metronidazole for another five days The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90 More importantly it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89 According to the Maastricht III consensus meeting it was recommended that susceptibility test should be done for patients who failed two treatments Therefore we aimed to assess the efficacy of susceptibility test driven sequential therapy as the third line therapy for those who fail from two standard eradication therapies
Methods This will be a multi-center open labeled pilot study
1 Patients
Open labeled non-comparative pilot study
2 Testing for H pylori infection
Before salvage treatment
either 1 any two positive of CLO test histology and culture or 2 a positive C13-UBT will be considered as failure of previous eradication treatment EGD with gastric biopsy will be done for H pylori culture and susceptibility test
After salvage treatment C13-UBT will be used to assess the existence of H pylori after 2nd or 3rd line salvage therapy
3 Treatment regimens and assignment
D1-7 Nexium 40 mg bid Amolin 1 gm bid
D8-14 Nexium 40 mg bid Flagyl 500 mg bid plus either one of the following according to antibiotic susceptibility test 1 Klaricid 500 mg bid or 2 Cravit 250 mg bid or 3 Tetracycline 500 mg bid
4 Outcome Measurement
Primary End Point Eradication rate will be evaluated according to Intent-to-treat ITT and per-protocol PP analyses
Secondary End Point the eradication rate according to antibiotic susceptibility before salvage therapy
Methods This will be a multi-center open labeled pilot study
1 Patients
Open labeled non-comparative pilot study
2 Testing for H pylori infection
Before salvage treatment
either 1 any two positive of CLO test histology and culture or 2 a positive C13-UBT will be considered as failure of previous eradication treatment EGD with gastric biopsy will be done for H pylori culture and susceptibility test
After salvage treatment C13-UBT will be used to assess the existence of H pylori after 2nd or 3rd line salvage therapy
3 Treatment regimens and assignment
D1-7 Nexium 40 mg bid Amolin 1 gm bid
D8-14 Nexium 40 mg bid Flagyl 500 mg bid plus either one of the following according to antibiotic susceptibility test 1 Klaricid 500 mg bid or 2 Cravit 250 mg bid or 3 Tetracycline 500 mg bid
4 Outcome Measurement
Primary End Point Eradication rate will be evaluated according to Intent-to-treat ITT and per-protocol PP analyses
Secondary End Point the eradication rate according to antibiotic susceptibility before salvage therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None