Back to resultsSusceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
Primary Purpose
Helicobacter Pylori Infection
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
clarithromycin-sensitive(first-line)
clarithromycin-resistant(first-line)
empirical therapy group first-line
levofloxacin-sensitive(rescue treatment)
levofloxacin-resistant(rescue treatment)
empirical therapy group rescue treatment
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Drug Resistance, Microbial, Microbial Sensitivity Tests
Eligibility Criteria
Inclusion Criteria:
- H. pylori infection was determined using at least one of the following tests: 13C/14C-urea breath test (UBT), stool H. pylori antigen test, rapid urease test, and histological analysis within 4 weeks.
- Patients were naïve to H. pylori treatment.
Exclusion Criteria:
- Allergy to any drug administered.
- Pregnancy and lactation.
- Major systemic diseases, such as severe cardiopulmonary or liver dysfunction.
- Complicated with active peptic ulcer disease, gastric cancer, or prior gastrectomy.
Sites / Locations
- Liaocheng people's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Arm Label
clarithromycin-sensitive(first-line)
clarithromycin-resistant(first-line)
empirical therapy group first-line
levofloxacin-sensitive(rescue treatment)
levofloxacin-resistant(rescue treatment)
empirical therapy group rescue treatment
Arm Description
If H. pylori is sensitive to clarithromycin, we will administer clarithromycin triple therapy-esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily)-for 14 days
If H. pylori is clarithromycin resistance, we selected the High-dose dual therapy (HDDT) regimen as first-line treatment. HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used for 14 days.
The empirical therapy group will receive Bismuth-containing quadruple therapy(BQT) as first-line treatment, The BQT regime is comprising of esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days.
If H. pylori was levofloxacin-sensitive, we will use the levofloxacin quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days.
If H. pylori was levofloxacin-resistant, we will use furazolidone quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days.
If BQT fails, HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used as a rescue treatment for 14 days.
Outcomes
Primary Outcome Measures
the first-line H. pylori eradication rate
the proportion of participants with successful H. pylori eradication, as determined by 13C-Urea breath test(UBT), at least 4 weeks after the end of the first-line treatment period between Susceptibility-guided therapy(SGT) and empirical therapy(ET) group.
Secondary Outcome Measures
the rescue H. pylori eradication rate
The second line eradication rate between SGT and ET group.
the overall H.pylori eradication rate
the total H.pylori eradication rate (first-line and second-line)between SGT and ET group.
high-dose dual therapy eradication rate
compare H. pylori eradication rate between clarithromycin resistance group and empirical BQT failure group.
Adverse events and compliance
3 days after the completion of therapy according to a data collection form
Full Information
NCT ID
NCT05549115
First Posted
September 18, 2022
Last Updated
December 15, 2022
Sponsor
Liaocheng People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05549115
Brief Title
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
Official Title
Susceptibility-Guided Sequential Therapy Versus Empirical Therapy for Helicobacter Pylori Infection: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liaocheng People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy.
Detailed Description
This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study. For empirical therapy group(control group), Bismuth quadruple therapy will be an empirical first-line therapy, and high dose dual (proton-pump inhibitor + amoxicillin) treatment will be for rescue therapy if the first-line empirical treat failure. For the susceptibility-guided sequential therapy group, regimens were selected based on H. pylori susceptibility to clarithromycin and levofloxacin. The primary outcome is the first-line eradication rate in both groups, and the overall (including first- and rescue therapies) H. pylori eradication rates in both groups is one of the secondary outcomes. The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis and per-protocol analysis.
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, Drug Resistance, Microbial, Microbial Sensitivity Tests
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
clarithromycin-sensitive(first-line)
Arm Type
Experimental
Arm Description
If H. pylori is sensitive to clarithromycin, we will administer clarithromycin triple therapy-esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily)-for 14 days
Arm Title
clarithromycin-resistant(first-line)
Arm Type
Experimental
Arm Description
If H. pylori is clarithromycin resistance, we selected the High-dose dual therapy (HDDT) regimen as first-line treatment. HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used for 14 days.
Arm Title
empirical therapy group first-line
Arm Type
Active Comparator
Arm Description
The empirical therapy group will receive Bismuth-containing quadruple therapy(BQT) as first-line treatment, The BQT regime is comprising of esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days.
Arm Title
levofloxacin-sensitive(rescue treatment)
Arm Type
Experimental
Arm Description
If H. pylori was levofloxacin-sensitive, we will use the levofloxacin quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days.
Arm Title
levofloxacin-resistant(rescue treatment)
Arm Type
Experimental
Arm Description
If H. pylori was levofloxacin-resistant, we will use furazolidone quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days.
Arm Title
empirical therapy group rescue treatment
Arm Type
Active Comparator
Arm Description
If BQT fails, HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used as a rescue treatment for 14 days.
Intervention Type
Drug
Intervention Name(s)
clarithromycin-sensitive(first-line)
Other Intervention Name(s)
clarithromycin triple therapy
Intervention Description
esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
Intervention Type
Drug
Intervention Name(s)
clarithromycin-resistant(first-line)
Other Intervention Name(s)
High-dose PPI-amoxicillin dual therapy
Intervention Description
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
Intervention Type
Drug
Intervention Name(s)
empirical therapy group first-line
Other Intervention Name(s)
Bismuth-containing quadruple therapy
Intervention Description
esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
Intervention Type
Drug
Intervention Name(s)
levofloxacin-sensitive(rescue treatment)
Other Intervention Name(s)
levofloxacin quadruple regimen
Intervention Description
esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days
Intervention Type
Drug
Intervention Name(s)
levofloxacin-resistant(rescue treatment)
Other Intervention Name(s)
furazolidone quadruple regimen
Intervention Description
esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days
Intervention Type
Drug
Intervention Name(s)
empirical therapy group rescue treatment
Other Intervention Name(s)
High-dose PPI-amoxicillin dual therapy
Intervention Description
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
Primary Outcome Measure Information:
Title
the first-line H. pylori eradication rate
Description
the proportion of participants with successful H. pylori eradication, as determined by 13C-Urea breath test(UBT), at least 4 weeks after the end of the first-line treatment period between Susceptibility-guided therapy(SGT) and empirical therapy(ET) group.
Time Frame
4-8 weeks after the end of treatment.
Secondary Outcome Measure Information:
Title
the rescue H. pylori eradication rate
Description
The second line eradication rate between SGT and ET group.
Time Frame
4-8 weeks after the second treatment
Title
the overall H.pylori eradication rate
Description
the total H.pylori eradication rate (first-line and second-line)between SGT and ET group.
Time Frame
4-8 weeks after the second treatment
Title
high-dose dual therapy eradication rate
Description
compare H. pylori eradication rate between clarithromycin resistance group and empirical BQT failure group.
Time Frame
4-8 weeks after the second treatment
Title
Adverse events and compliance
Description
3 days after the completion of therapy according to a data collection form
Time Frame
3 days after the end of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
H. pylori infection was determined using at least one of the following tests: 13C/14C-urea breath test (UBT), stool H. pylori antigen test, rapid urease test, and histological analysis within 4 weeks.
Patients were naïve to H. pylori treatment.
Exclusion Criteria:
Allergy to any drug administered.
Pregnancy and lactation.
Major systemic diseases, such as severe cardiopulmonary or liver dysfunction.
Complicated with active peptic ulcer disease, gastric cancer, or prior gastrectomy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing run Zhao, Dr
Phone
+86-635-8276373
Email
zhjrun77@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing run Zhao, Dr
Organizational Affiliation
Liaocheng People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Liaocheng people's hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingrun Zhao, Dr
Phone
+86-635-8276373
Email
zhjrun77@163.com
12. IPD Sharing Statement
Learn more about this trial
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
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