Back to resultsAntimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.
Primary Purpose
Helicobacter Pylori Infection, Antimicrobial Susceptibility Testing
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)
two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)
one proton pump inhibitor(PPI)
Colloidal Bismuth Pectin
two antibiotics for failed eradication(tetracyclin,furazolidone)
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter Pylori Infection, Antimicrobial Susceptibility testing(AST)
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18-70 with H. pylori infection.
Exclusion Criteria:
- Patients with previous H. pylori eradication therapy;
- Patients unable or unwilling to receive gastroscopy;
- Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks;
- Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- Patients with known or suspected allergy to study medications;
- Currently pregnant or lactating;
- Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Sites / Locations
- Xiuli Zuo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Other
Other
Arm Label
Antimicrobial susceptibility testing guided therapy
Empirical tailored therapy
Salvage therapy for negative culture
Salvage therapy for failed eradication
Arm Description
Patients in this group will receive a 10-day triple therapy for the Helicobacter pylori eradication. The regimen contains one proton pump inhibitor and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 10d 2.two sensitive antibiotics: amoxicillin 1000mg bid for 10d, clarithromycin 500mg bid for 10d, metronidazole 500mg tid for 10d, tinidazole 500mg tid for 10d, levofloxacin 500mg qd for 10d, furazolidone 100mg bid for 10d, tetracycline 750mg bid for 10d.
Patients in this group will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.
When the culture results are negative, patients will receive 14-day empirical tailored therapy based on personal medication history. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.
If patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics for rescue therapy: tetracycline 750mg bid and furazolidone 100mg bid for 14d.
Outcomes
Primary Outcome Measures
Eradication rates in 2 groups
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Secondary Outcome Measures
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.
Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.
The rate of adverse events happening
Similarly, adverse events will also be measured by the Likert scale.
The rate of good compliance
Patients taken over 90% of drugs are considered to have a good compliance.
Difference of cost per patient for each eradication achieved in two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03571230
Brief Title
Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.
Official Title
10-Day Antimicrobial Susceptibility Testing Guided Triple Therapy Versus 14-Day Empirical Tailored Therapy for the First-line Treatment of Helicobacter Pylori Infection-A Randomized Controlled Trail
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
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 purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.
Detailed Description
Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies. Antimicrobial susceptibility test can pick out sensitive drugs to kill Helicobacter pylori, and reduce secondary drug resistance. But, there is a lack of high quality RCT to compare its efficacy with empirical regimen in the first-line treatment.
Our study aims to assess the efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection. Comparing this regimen with 14-day Empirical Tailored Therapy to tell which one is better in clinic practice. We also want to find whether the 10-day antimicrobial susceptibility test guided triple therapy has less intestinal dysbacteriosis with a shorter duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Antimicrobial Susceptibility Testing
Keywords
Helicobacter Pylori Infection, Antimicrobial Susceptibility testing(AST)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antimicrobial susceptibility testing guided therapy
Arm Type
Experimental
Arm Description
Patients in this group will receive a 10-day triple therapy for the Helicobacter pylori eradication. The regimen contains one proton pump inhibitor and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 10d 2.two sensitive antibiotics: amoxicillin 1000mg bid for 10d, clarithromycin 500mg bid for 10d, metronidazole 500mg tid for 10d, tinidazole 500mg tid for 10d, levofloxacin 500mg qd for 10d, furazolidone 100mg bid for 10d, tetracycline 750mg bid for 10d.
Arm Title
Empirical tailored therapy
Arm Type
Experimental
Arm Description
Patients in this group will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.
Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.
Arm Title
Salvage therapy for negative culture
Arm Type
Other
Arm Description
When the culture results are negative, patients will receive 14-day empirical tailored therapy based on personal medication history.
Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.
Arm Title
Salvage therapy for failed eradication
Arm Type
Other
Arm Description
If patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy.
Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics for rescue therapy: tetracycline 750mg bid and furazolidone 100mg bid for 14d.
Intervention Type
Drug
Intervention Name(s)
two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)
Intervention Description
Patients will receive a 10-day triple therapy for the H.pylori eradication. The regimen contains one PPI and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
Intervention Type
Drug
Intervention Name(s)
two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)
Intervention Description
Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.
Intervention Type
Drug
Intervention Name(s)
one proton pump inhibitor(PPI)
Intervention Description
All the patients need this drug.
Intervention Type
Drug
Intervention Name(s)
Colloidal Bismuth Pectin
Intervention Description
All the patients treated with 14-day bismuth-based quadruple therapy need this drug.
Intervention Type
Drug
Intervention Name(s)
two antibiotics for failed eradication(tetracyclin,furazolidone)
Intervention Description
If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains one PPI, Colloidal Bismuth Pectin, tetracycline and furazolidone.
Primary Outcome Measure Information:
Title
Eradication rates in 2 groups
Description
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.
Description
Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.
Time Frame
6 months
Title
The rate of adverse events happening
Description
Similarly, adverse events will also be measured by the Likert scale.
Time Frame
6 months
Title
The rate of good compliance
Description
Patients taken over 90% of drugs are considered to have a good compliance.
Time Frame
6 months
Title
Difference of cost per patient for each eradication achieved in two groups
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18-70 with H. pylori infection.
Exclusion Criteria:
Patients with previous H. pylori eradication therapy;
Patients unable or unwilling to receive gastroscopy;
Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks;
Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
Patients with known or suspected allergy to study medications;
Currently pregnant or lactating;
Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Zuo, PhD,MD
Phone
15588818685
Ext
053188369277
Email
zuoxiuli@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, PhD,MD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiuli Zuo
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, PhD,MD
Phone
15588818685
Ext
053188369277
Email
zuoxiuli@sina.com
First Name & Middle Initial & Last Name & Degree
Jing Liu, MD
First Name & Middle Initial & Last Name & Degree
Chaoran Ji, MD
12. IPD Sharing Statement
Learn more about this trial
Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.
We'll reach out to this number within 24 hrs