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Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

Primary Purpose

Helicobacter Pylori Infection

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Esomeprazole

Bismuth potassium citrate

Metronidazole

Clarithromycin

Levofloxacin

Amoxicillin

Tetracycline

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Renji Hospital, School of Medicine, Shanghai Jiaotong University
Zhongshan Hospital, Fudan UniversityRecruiting
Huashan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Genotypic resistance guided therapy

Phenotypic resistance guided therapy

Empiric therapy

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Eradication rate of Helicobacter pylori

Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05250050

First Posted

February 11, 2022

Last Updated

March 16, 2022

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05250050

Brief Title

Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

Official Title

Clinical Efficacy and Health Economic Evaluation of Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment：Multicenter Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 25, 2022 (Anticipated)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helicobacter Pylori Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

The technicians, who performed culture, antimicrobial susceptibility testing or urea breath test were blinded to treatment allocation.

Allocation

Randomized

Enrollment

388 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Genotypic resistance guided therapy

Arm Type

Experimental

Arm Description

Arm Title

Phenotypic resistance guided therapy

Arm Type

Experimental

Arm Description

Arm Title

Empiric therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Intervention Description

20mg bid

Intervention Type

Drug

Intervention Name(s)

Bismuth potassium citrate

Intervention Description

0.6g bid

Intervention Type

Drug

Intervention Name(s)

Metronidazole

Intervention Description

0.4g qid

Intervention Type

Drug

Intervention Name(s)

Clarithromycin

Intervention Description

0.5g bid

Intervention Type

Drug

Intervention Name(s)

Levofloxacin

Intervention Description

0.5g qd

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Intervention Description

1g bid

Intervention Type

Drug

Intervention Name(s)

Tetracycline

Intervention Description

0.5g qid

Primary Outcome Measure Information:

Title

Eradication rate of Helicobacter pylori

Description

Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Eradication rate of Helicobacter pylori resistant strains

Description

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.

Time Frame

6 weeks

Title

Eradication rate of Helicobacter pylori susceptible strains

Description

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.

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

Adherence rate

Description

The proportion of subjects with good adherence. Good adherence was defined as that subjects took more than 80% of the total medication.

Time Frame

2 weeks during therapy

Title

Frequency of adverse events

Description

Any possible adverse events during the 14-day treatment period were recorded.

Time Frame

2 weeks during therapy

Title

Average cost of each group

Description

Average medical cost related to therapy and followup in each group

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qi Chen, MD

Phone

86-17811921405

chenqimd@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hong Gao, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renji Hospital, School of Medicine, Shanghai Jiaotong University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hong Lu, MD

Phone

+86-021-58752345

hlu@sjtu.edu.cn

First Name & Middle Initial & Last Name & Degree

Hong Lu, MD

Facility Name

Zhongshan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qi Chen, MD

Phone

86-18817821405

chenqimd@163.com

First Name & Middle Initial & Last Name & Degree

Hong Gao, MD

First Name & Middle Initial & Last Name & Degree

Qi Chen, MD

First Name & Middle Initial & Last Name & Degree

Tiancheng Luo, MD

First Name & Middle Initial & Last Name & Degree

Ningping Zhang, MD

First Name & Middle Initial & Last Name & Degree

Shenglei Huang, MD

First Name & Middle Initial & Last Name & Degree

Chunmei Zhou, MD

First Name & Middle Initial & Last Name & Degree

Wei Guo, MD

Facility Name

Huashan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Liu, MD

Phone

+86-021-52889999

yiliu@fudan.edu.cn

First Name & Middle Initial & Last Name & Degree

Yi Liu, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

http://clinicaltrials.gov/

Learn more about this trial

Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

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