Ignite Creation Date:
2024-05-06 @ 10:03 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03148366
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2015-01-30
Brief Title:
Comparison of the Levofloxacin Sequential Therapy and Quadruple Therapy in Second Line Treatment for HP
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Bismuth Quadruple Therapy in the Second Line and Third Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Objectives Eradication of H pylori infection could reduce the occurence or recurrence of gastric cancer and peptic ulcer 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 Bismuth quadruple therapy and triple therapy containing levofloxacin are currently the recommended rescue therapies in the second line and third line treatment Recently our pilot study showed that modified sequential therapy containing levofloxacin achieved high eradication rate 95 in the second line therapy The regimen includes a PPI plus amoxicillin for 5-7 days followed by a PPI plus levofloxacin and metronidazole for another 5-7 days However whether this modified sequential therapy containing levofloxacin is more effective than bismuth quadruple therapy in the second line and third line treatment remains unknown Besides the impact of these regimens on the antibiotic resistance microbiota of gut flora and metabolic factors remains unknown
Aims Therefore the investigators aimed to
1 compare the eradication rates and long term re-infection rates of sequential therapy containing levofloxacin for 14 days versus bismuth quadruple therapy for 10 days in the second line and third line treatment
2 assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
3 assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
4 assess the impact of eradication therapy on the metabolic factors
Aims Therefore the investigators aimed to
1 compare the eradication rates and long term re-infection rates of sequential therapy containing levofloxacin for 14 days versus bismuth quadruple therapy for 10 days in the second line and third line treatment
2 assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
3 assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
4 assess the impact of eradication therapy on the metabolic factors
Detailed Description:
Methods
This will be a multi-center open labeled randomized comparative trial with cross-over design Patients Participants with refractory H pylori infection after one eradication therapy
Testing for H pylori infection Before Second Line Treatment Any two positive of CLO test histology and culture or a positive UBT will be considered as H pylori infected
After Second Line Treatment C13-UBT will be used to assess the existence of H pylori 6-8 weeks after first line therapy
Long term reinfection C13-UBT will be used to assess the recurrence of H pylori 1 year after eradication therapy
Interventions
Second line therapy eligible patients will be randomized into one of the two groups Group A sequential therapy containing levofloxacin for 14 days EAML D1-D7 esomeprazole 40mg bid amoxicillin 1gm bid for 7 days D8-D14 esomeprazole 40mg bid levofloxacin 250mg bid metronidazole 500mg bid for another 7 days
Group B bismuth quadruple therapy for 10 days BQ D1-D10 esomeprazole 40mg bid Dibismuth trioxide 120mg qid metronidazole 500mg tid tetracycline 500mg qid for 10 days
Third line therapy patients who fail from second line treatment will be rescue with the following treatment Group A Patient who fail from levofloxacin sequential therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10 esomeprazole 40mg bid Dibismuth trioxide 120mg qid metronidazole 500mg tid tetracycline 500mg qid for 10 days
Group B Patient who fail from bismuth quadruple therapy will be retreated with levofloxacin sequential therapy for 14days D1-D7 esomeprazole 40mg bid amoxicillin 1gm bid for 7 days D8-D14 esomeprazole 40mg bid levofloxacin 250mg bid metronidazole 500mg bid for another 7 days
Outcome Measurement
Primary End Point Eradication rate in the second line according to intention to treat ITT and per-protocol PP analysis in the two treatment groups
This will be a multi-center open labeled randomized comparative trial with cross-over design Patients Participants with refractory H pylori infection after one eradication therapy
Testing for H pylori infection Before Second Line Treatment Any two positive of CLO test histology and culture or a positive UBT will be considered as H pylori infected
After Second Line Treatment C13-UBT will be used to assess the existence of H pylori 6-8 weeks after first line therapy
Long term reinfection C13-UBT will be used to assess the recurrence of H pylori 1 year after eradication therapy
Interventions
Second line therapy eligible patients will be randomized into one of the two groups Group A sequential therapy containing levofloxacin for 14 days EAML D1-D7 esomeprazole 40mg bid amoxicillin 1gm bid for 7 days D8-D14 esomeprazole 40mg bid levofloxacin 250mg bid metronidazole 500mg bid for another 7 days
Group B bismuth quadruple therapy for 10 days BQ D1-D10 esomeprazole 40mg bid Dibismuth trioxide 120mg qid metronidazole 500mg tid tetracycline 500mg qid for 10 days
Third line therapy patients who fail from second line treatment will be rescue with the following treatment Group A Patient who fail from levofloxacin sequential therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10 esomeprazole 40mg bid Dibismuth trioxide 120mg qid metronidazole 500mg tid tetracycline 500mg qid for 10 days
Group B Patient who fail from bismuth quadruple therapy will be retreated with levofloxacin sequential therapy for 14days D1-D7 esomeprazole 40mg bid amoxicillin 1gm bid for 7 days D8-D14 esomeprazole 40mg bid levofloxacin 250mg bid metronidazole 500mg bid for another 7 days
Outcome Measurement
Primary End Point Eradication rate in the second line according to intention to treat ITT and per-protocol PP analysis in the two treatment groups
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