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Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
susceptibility-guided tailored therapy (Group A)
guidelines-recommended empiric therapy (Group B)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, antimicrobial susceptibility testing, minimal inhibitory concentration, susceptibility-guided tailored therapy, guideline-recommended empiric therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients, aged >= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens.

Exclusion Criteria:

  1. pregnant or nursing woman;
  2. serious concomitant illness and malignant tumor of any kind;
  3. history of hypersensitivity to test drugs;
  4. serious bleeding during the course of this ulcer;
  5. previous gastric surgery;
  6. receiving bismuth salts, PPIs, or antibiotics in the previous month.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

susceptibility-guided tailored therapy (Group A)

guidelines-recommended empiric therapy (Group B)

Arm Description

Includes 5 treatment options. The priority order of treatment regimens is based on the selection principal through AST with MIC profile. 1. clarithromycin triple therapy: include rabeprazole 20mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid, for 14 days; or 2. levofloxacin triple therapy: include rapeprazole 20 mg bid, amoxicillin 1 g bid, and levofloxacin 500 mg bid, for 14 days; or 3. metronidazole triple therapy: include rabeprazole 20 mg bid, amoxicillin 500 mg qid, and metronidazole 250 mg qid, for 14 days; or 4. high-dose dual therapy: include rabeprazole 20 mg qid, amoxicillin 750 mg qid, for 14 days; or 5. bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.

bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.

Outcomes

Primary Outcome Measures

to compare the eradication rate of SG-TT with GR-ET as rescue regimens for H. pylori eradication.
The eradication rate (efficacy) of these regimens will be evaluated by the result of C13-UBT in intention-to treat (ITT) and per-protocol (PP) analysis.

Secondary Outcome Measures

to compare the patient adherence and frequency of adverse effects of these treatment regimens
The frequency of adverse events will be evaluated by the number of participant with adverse events and patient adherence will be evaluated by counting unused medication after the treatment.

Full Information

First Posted
April 10, 2022
Last Updated
June 15, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05332444
Brief Title
Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection
Official Title
Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective Randomized, Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The prevalence of H. pylori antibiotic resistance has reached an alarming level worldwide. Antibiotic stewardship programs should be urgently developed and implemented. However, H. pylori antimicrobial susceptibility testing (AST) is rarely offered, making local resistance patterns not easily available. Guideline-recommended empiric therapies (GR-ET) may no longer reliably achieve high cure rate in the era of increasing antibiotic resistance. susceptibility-guided tailored therapy (SG-TT) may be a good choice to solve this problem. The aims of this study are: to compare the efficacy of SG-TT with GR-ET as rescue regimens for H. pylori eradication; to compare the patient adherence and adverse effects of these treatment regimens; to investigate factors that may influence H. pylori eradication by these treatment regimens.
Detailed Description
This prospective multicenter randomized comparative study will be conducted at the National Taiwan University Hospital, NTUH Bei-Hu Branch, NTUH Hsin-Chu Branch, Taipei City Hospital Renai Branch, Buddhist Tzu Chi General Hospital, and Mennonite Christian Hospital in Hualien. The study protocol will be approved by the independent ethics boards or committees of each hospital. Patients, aged >= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. If the patients failed anti-H. pylori therapy previously, these patients will be invited to enter this study for evaluating the efficacy of these rescue regimens. A computed generated random numbers sequence will be blocked (1:1; block size 6) into two subgroups, say A, and B. After giving written informed consent, each patient will be randomly allocated, to one of two treatment groups: group A - SG-TT (susceptibility-guided tailored therapy) : treated with 1. clarithromycin triple therapy, or 2. levofloxacin triple therapy, or 3. metronidazole triple therapy, or 4. high-dose dual therapy, or 5. bismuth quadruple therapy, by priority order base on the selection principal through AST with MIC profile; group B -GR-ET (guidelines-recommended empiric therapy): treated with bismuth quadruple therapy. All patients will be asked to complete a questionnaire and to record symptoms and drug consumption, and diet content daily during the treatment period. Post-treatment, the patients will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effects of treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test (UBT). The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, antimicrobial susceptibility testing, minimal inhibitory concentration, susceptibility-guided tailored therapy, guideline-recommended empiric therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
susceptibility-guided tailored therapy (Group A)
Arm Type
Experimental
Arm Description
Includes 5 treatment options. The priority order of treatment regimens is based on the selection principal through AST with MIC profile. 1. clarithromycin triple therapy: include rabeprazole 20mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid, for 14 days; or 2. levofloxacin triple therapy: include rapeprazole 20 mg bid, amoxicillin 1 g bid, and levofloxacin 500 mg bid, for 14 days; or 3. metronidazole triple therapy: include rabeprazole 20 mg bid, amoxicillin 500 mg qid, and metronidazole 250 mg qid, for 14 days; or 4. high-dose dual therapy: include rabeprazole 20 mg qid, amoxicillin 750 mg qid, for 14 days; or 5. bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.
Arm Title
guidelines-recommended empiric therapy (Group B)
Arm Type
Active Comparator
Arm Description
bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.
Intervention Type
Drug
Intervention Name(s)
susceptibility-guided tailored therapy (Group A)
Other Intervention Name(s)
Proton pump inhibitor: Rabeprazole, Pariet®, Antibiotics: Amoxicillin, Amoxicillin®; Clarithromycin, Klaricid®; Levofloxacin, Cravit®; Metronidazole, Metrozole®; Tetracyclline, tetracycline®, Colloidal Bismuth: Tripotassium dicitrate bismuthate, KCB®
Intervention Description
Includes 5 treatment options. The priority order of treatment regimens is based on the selection principal through AST with MIC profile. 1. clarithromycin triple therapy: include rabeprazole 20mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid, for 14 days; or 2. levofloxacin triple therapy: include rapeprazole 20 mg bid, amoxicillin 1 g bid, and levofloxacin 500 mg bid, for 14 days; or 3. metronidazole triple therapy: include rabeprazole 20 mg bid, amoxicillin 500 mg qid, and metronidazole 250 mg qid, for 14 days; or 4. high-dose dual therapy: include rabeprazole 20 mg qid, amoxicillin 750 mg qid, for 14 days; or 5. bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.
Intervention Type
Drug
Intervention Name(s)
guidelines-recommended empiric therapy (Group B)
Other Intervention Name(s)
Proton pump inhibitor: Rabeprazole, Pariet®, Antibiotics: Metronidazole, Metrozole®; Tetracyclline, tetracycline®, Colloidal Bismuth: Tripotassium dicitrate bismuthate, KCB®
Intervention Description
bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.
Primary Outcome Measure Information:
Title
to compare the eradication rate of SG-TT with GR-ET as rescue regimens for H. pylori eradication.
Description
The eradication rate (efficacy) of these regimens will be evaluated by the result of C13-UBT in intention-to treat (ITT) and per-protocol (PP) analysis.
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
to compare the patient adherence and frequency of adverse effects of these treatment regimens
Description
The frequency of adverse events will be evaluated by the number of participant with adverse events and patient adherence will be evaluated by counting unused medication after the treatment.
Time Frame
3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients, aged >= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens. Exclusion Criteria: pregnant or nursing woman; serious concomitant illness and malignant tumor of any kind; history of hypersensitivity to test drugs; serious bleeding during the course of this ulcer; previous gastric surgery; receiving bismuth salts, PPIs, or antibiotics in the previous month.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jyh-Chin Yang, M.D.Ph.D.
Phone
02-23123456
Ext
265055
Email
jcyang47@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Chih Tung, M.D.
Phone
02-23123456
Ext
266518
Email
cnicemike@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyh-Chin Yang, M.D.Ph.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyh-Chin Yang, M.D.Ph.D.
Phone
0223123456
Ext
65055
Email
jcyang47@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection

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