Back to resultsRescue Therapy for Helicobacter Pylori Infection
Primary Purpose
Helicobacter Pylori Infection
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vonoprazan
Bismuth Potassium Citrate
Tetracycline
Metronidazole
Amoxicillin
Rifabutin
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, rescue therapy
Eligibility Criteria
Inclusion Criteria: Ability and willingness to participate in the study and to sign and give informed consent Confirmed H. pylori infection and with previous treatment experience Exclusion Criteria: subjects naive to H. pylori treatment, under 18 or over 80 years old history of gastrectomy pregnant or lactating women Previous history of tuberculosis Allergy to any of the study drugs severe systemic diseases or malignancy administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Sites / Locations
- Renji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting
- Shanghai Songjiang District Central HospitalRecruiting
- The Second Affiliated Hospital of Zhejiang University school of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Tetracycline Bismuth Quadruple Therapy
Rifabutin Triple Therapy
Dual Therapy
Arm Description
Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid
Vonoprazan 20mg bid, amoxicillin 1000mg tid
Outcomes
Primary Outcome Measures
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
Secondary Outcome Measures
Rate of adverse effects
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or severe" (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney.
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication
Full Information
NCT ID
NCT05874544
First Posted
May 16, 2023
Last Updated
October 23, 2023
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05874544
Brief Title
Rescue Therapy for Helicobacter Pylori Infection
Official Title
Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
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
Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.
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, rescue therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
357 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tetracycline Bismuth Quadruple Therapy
Arm Type
Active Comparator
Arm Description
Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Arm Title
Rifabutin Triple Therapy
Arm Type
Experimental
Arm Description
Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid
Arm Title
Dual Therapy
Arm Type
Experimental
Arm Description
Vonoprazan 20mg bid, amoxicillin 1000mg tid
Intervention Type
Drug
Intervention Name(s)
Vonoprazan
Intervention Description
Proton pump inhibitor
Intervention Type
Drug
Intervention Name(s)
Bismuth Potassium Citrate
Intervention Description
Gastric mucosal protective drug with anti-H. pylori effect
Intervention Type
Drug
Intervention Name(s)
Tetracycline
Intervention Description
Antibiotics for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Antibiotics for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Antibiotics for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
Rifabutin
Intervention Description
Antibiotics for H. pylori eradication
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication rate
Description
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
Time Frame
Six weeks after completion of therapy
Secondary Outcome Measure Information:
Title
Rate of adverse effects
Description
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or severe" (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney.
Time Frame
Within 7 days after completion of therapy
Title
Compliance rate
Description
Compliance was defined as poor when they had taken less than 80% of the total medication
Time Frame
Within 7 days after completion of therapy
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:
Ability and willingness to participate in the study and to sign and give informed consent
Confirmed H. pylori infection and with previous treatment experience
Exclusion Criteria:
subjects naive to H. pylori treatment,
under 18 or over 80 years old
history of gastrectomy
pregnant or lactating women
Previous history of tuberculosis
Allergy to any of the study drugs
severe systemic diseases or malignancy
administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Facility Information:
Facility Name
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Huang, M.M.
Phone
86+18621791879
Email
15626211482@163.com
First Name & Middle Initial & Last Name & Degree
Hong Lu, M.D.,Ph.D
First Name & Middle Initial & Last Name & Degree
Jinnan Chen, M.M.
First Name & Middle Initial & Last Name & Degree
Yixian Guo, M.M.
First Name & Middle Initial & Last Name & Degree
Xiao Liang, M.D.,Ph.D
Facility Name
Shanghai Songjiang District Central Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Wang
Phone
18918289144
Email
wangj0081@126.com
Facility Name
The Second Affiliated Hospital of Zhejiang University school of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaohua Han
Phone
（0571）87783933
Email
doudouhan0926@sohu.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Rescue Therapy for Helicobacter Pylori Infection
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