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

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Esomeprazole; Drug: Clarithromycin; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Amoxicillin; Drug: Levofloxacin; Drug: Tetracycline

Detailed Description

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 treatment of Helicobacter pylori in patients with chronic gastritis. This study will compare the efficacy of individualized and empirical drug sensitivity regimens, and conduct cost-effectiveness analysis to provide pharmacoeconomic guidance for clinical decision-making. At the same time, it will provide reference for the reasonable pricing of H.pylori drug sensitivity test and considering the health benefits brought by its inclusion in medical insurance.

• Study Type: Interventional
• Enrollment (Anticipated): 388
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Principal Investigator: Hong Gao, MD
      • Sub-Investigator: Tiancheng Luo, MD
      • Sub-Investigator: Ningping Zhang, MD
      • Sub-Investigator: Shenglei Huang, MD
      • Sub-Investigator: Chunmei Zhou, MD
      • Sub-Investigator: Wei Guo, MD
    • Shanghai, Shanghai, China, 200040
      • Not yet recruiting
      • Huashan Hospital, Fudan University
      • Principal Investigator: Yi Liu, MD
      • Contact: Yi Liu, MD; Phone Number: +86-021-52889999; Email: yiliu@fudan.edu.cn
    • Shanghai, Shanghai, China, 200000
      • Not yet recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiaotong University
      • Contact: Hong Lu, MD; Phone Number: +86-021-58752345; Email: hlu@sjtu.edu.cn
      • Principal Investigator: Hong Lu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
• 18-75 years old on the day of signing the ICF.
• Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genotypic resistance guided therapy; After 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.	Drug: Esomeprazole; 20mg bid; Drug: Clarithromycin; 0.5g bid; Drug: Bismuth potassium citrate; 0.6g bid; Drug: Metronidazole; 0.4g qid; Drug: Amoxicillin; 1g bid; Drug: Levofloxacin; 0.5g qd; Drug: Tetracycline; 0.5g qid
Experimental: Phenotypic resistance guided therapy; After 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.	Drug: Esomeprazole; 20mg bid; Drug: Clarithromycin; 0.5g bid; Drug: Bismuth potassium citrate; 0.6g bid; Drug: Metronidazole; 0.4g qid; Drug: Amoxicillin; 1g bid; Drug: Levofloxacin; 0.5g qd; Drug: Tetracycline; 0.5g qid
Active Comparator: Empiric therapy; Esomeprazole 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	Drug: Esomeprazole; 20mg bid; Drug: Bismuth potassium citrate; 0.6g bid; Drug: Metronidazole; 0.4g qid; Drug: Amoxicillin; 1g bid; Drug: Tetracycline; 0.5g qid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate of Helicobacter pylori resistant strains	Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.	6 weeks
Eradication rate of Helicobacter pylori susceptible strains	Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events	Any possible adverse events during the 14-day treatment period were recorded.	2 weeks during therapy
Adherence rate	The proportion of subjects with good adherence. Good adherence was defined as that subjects took more than 80% of the total medication.	2 weeks during therapy
Average cost of each group	Average medical cost related to therapy and followup in each group	6 weeks

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Hong Gao, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 25, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Natriuretic Agents; Anti-Bacterial Agents; Diuretics; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Respiratory System Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Expectorants; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Metronidazole; Amoxicillin; Clarithromycin; Levofloxacin; Esomeprazole; Bismuth; Tetracycline; Potassium Citrate
• Other Study ID Numbers: B2021-831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months and ending 5 years after the trial results were published.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No