The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study
Primary Purpose
H. Pylori Infection
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Cravit-based sequential therapy
Sponsored by

About this trial
This is an interventional treatment trial for H. Pylori Infection focused on measuring Helicobacter pylori, sequential therapy, levofloxacin, clarithromycin, rescue, salvage, treatment failure, For those who fail from one standard eradication therapy for H. pylori infection
Eligibility Criteria
Inclusion Criteria:
- Patients are aged greater than 20 years who have persistent H. pylori infection after one treatment and are willing to receive second line rescue regimens, respectively, are considered eligible for enrollment.
Exclusion Criteria:
- Children and teenagers aged less than 20 years,
- History of gastrectomy,
- Gastric malignancy, including adenocarcinoma and lymphoma,
- Previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin) and prompt pump inhibitors (esomeprazole),
- Contraindication to treatment drugs,
- Pregnant or lactating women, OR
- Severe concurrent disease.
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cravit-based sequential therapy
Arm Description
Cravit-based sequential therapy Eligible patients will be treated with (esomeprazole 40mg bid +amoxicillin 1gm bid) for 5 days, followed by (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid ) for another 5 days
Outcomes
Primary Outcome Measures
Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses
Secondary Outcome Measures
Full Information
NCT ID
NCT00885417
First Posted
April 20, 2009
Last Updated
April 21, 2011
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00885417
Brief Title
The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study
Official Title
The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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:
Bismuth based quadruple therapy (combined with ranitidine or proton-pump inhibitor (PPI) plus two antibiotics)
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%.
Aims: Therefore, the investigators aim to assess the efficacy of levofloxacin-based sequential therapy as second line therapy for those who fail from one standard eradication therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
H. Pylori Infection
Keywords
Helicobacter pylori, sequential therapy, levofloxacin, clarithromycin, rescue, salvage, treatment failure, For those who fail from one standard eradication therapy for H. pylori infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cravit-based sequential therapy
Arm Type
Experimental
Arm Description
Cravit-based sequential therapy Eligible patients will be treated with (esomeprazole 40mg bid +amoxicillin 1gm bid) for 5 days, followed by (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid ) for another 5 days
Intervention Type
Drug
Intervention Name(s)
Cravit-based sequential therapy
Intervention Description
Eligible patients will be treated with (esomeprazole 40mg bid +amoxicillin 1gm bid) for 5 days, followed by (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid ) for another 5 days
Primary Outcome Measure Information:
Title
Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses
Time Frame
2009/4/20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are aged greater than 20 years who have persistent H. pylori infection after one treatment and are willing to receive second line rescue regimens, respectively, are considered eligible for enrollment.
Exclusion Criteria:
Children and teenagers aged less than 20 years,
History of gastrectomy,
Gastric malignancy, including adenocarcinoma and lymphoma,
Previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin) and prompt pump inhibitors (esomeprazole),
Contraindication to treatment drugs,
Pregnant or lactating women, OR
Severe concurrent disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyh-Ming Liou, MD
Organizational Affiliation
Nationa Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study
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