Back to resultsTailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy
Primary Purpose
Helicobacter Pylori Infection
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esomeprazole
Bismuth Potassium Citrate
Clarithromycin
Metronidazole
Levofloxacin
Tetracycline
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Tailored therapy, Penicillin allergy, Antimicrobial susceptibility testing
Eligibility Criteria
Inclusion Criteria:
- Participants with penicillin allergy who have non-ulcer functional dyspepsia or scarred peptic ulcer disease
- Ability and willingness to participate in the study and to sign and give informed consent
- confirmed H. pylori infection
Exclusion Criteria:
- Patients without penicillin allergy
- Less than 18 years old
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs
- Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Sites / Locations
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tailored Therapy
Arm Description
Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
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)
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication.
Full Information
NCT ID
NCT03708848
First Posted
January 13, 2018
Last Updated
December 9, 2019
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03708848
Brief Title
Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy
Official Title
Antibiotic Susceptibility-based Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy: a Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
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
Increasing drug resistance presents a significant challenge to the efficacies of common empiric eradication regimens for Helicobacter pylori treatment in the mainland of China. Tailored therapy may be the best choice to achieve good efficacy, especially in patients with penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored therapy for Helicobacter pylori treatment in the patients with penicillin allergy.
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, Tailored therapy, Penicillin allergy, Antimicrobial susceptibility testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid and two sensitive ones of clarithromycin, metronidazole,levofloxacin and tetracycline.
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored Therapy
Arm Type
Experimental
Arm Description
Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
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)
Clarithromycin
Intervention Description
antibiotic for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
antibiotic for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
antibiotic for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
Tetracycline
Intervention Description
antibiotic 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)
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
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with penicillin allergy who have non-ulcer functional dyspepsia or scarred peptic ulcer disease
Ability and willingness to participate in the study and to sign and give informed consent
confirmed H. pylori infection
Exclusion Criteria:
Patients without penicillin allergy
Less than 18 years old
With previous gastric surgery
Major systemic diseases
Pregnancy or lactation
Allergy to any of the study drugs
Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Lu, M.D.,Ph.D.
Organizational Affiliation
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32428369
Citation
Luo L, Huang Y, Liang X, Ji Y, Yu L, Lu H. Susceptibility-guided therapy for Helicobacter pylori-infected penicillin-allergic patients: A prospective clinical trial of first-line and rescue therapies. Helicobacter. 2020 Aug;25(4):e12699. doi: 10.1111/hel.12699. Epub 2020 May 19.
Results Reference
derived
Learn more about this trial
Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy
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