Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment
Clinical Efficacy and Health Economic Evaluation of Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment：Multicenter Randomized Controlled Study
1 other identifier
interventional
388
1 country
3
Brief Summary
This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the Helicobacter pylori treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2022
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedStudy Start
First participant enrolled
March 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedMarch 18, 2022
March 1, 2022
9 months
February 11, 2022
March 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Eradication rate of Helicobacter pylori
Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).
6 weeks
Secondary Outcomes (2)
Eradication rate of Helicobacter pylori resistant strains
6 weeks
Eradication rate of Helicobacter pylori susceptible strains
6 weeks
Other Outcomes (3)
Adherence rate
2 weeks during therapy
Frequency of adverse events
2 weeks during therapy
Average cost of each group
6 weeks
Study Arms (3)
Genotypic resistance guided therapy
EXPERIMENTALAfter Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Phenotypic resistance guided therapy
EXPERIMENTALAfter antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Empiric therapy
ACTIVE COMPARATOREsomeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g bid (no penicillin allergy) OR tetracycline 0.5g qid (penicillin allergy) for 14 days
Interventions
20mg bid
0.6g bid
0.4g qid
1g bid
0.5g qid
Eligibility Criteria
You may qualify if:
- Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
- years old on the day of signing the ICF.
- Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
You may not qualify if:
- Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
- Subjects or guardians refused to participate in the trial.
- Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
- Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
- Pregnant or lactating women.
- Active peptic ulcer.
- allergic to drugs used in the trial.
- any other circumstances that are not suitable for recruitment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200000, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Gao, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The technicians, who performed culture, antimicrobial susceptibility testing or urea breath test were blinded to treatment allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 22, 2022
Study Start
March 25, 2022
Primary Completion
December 30, 2022
Study Completion
March 1, 2023
Last Updated
March 18, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 6 months and ending 5 years after the trial results were published.
- Access Criteria
- All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Hong Gao at gao.hong@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.