Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05250050

Collaborator

(none)

388

Enrollment

Locations

Arms

11.2

Anticipated Duration (Months)

129.3

Patients Per Site

11.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Esomeprazole Drug: Bismuth potassium citrate Drug: Metronidazole Drug: Clarithromycin Drug: Levofloxacin Drug: Amoxicillin Drug: Tetracycline	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

388 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 25, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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: Bismuth potassium citrate 0.6g bid Drug: Metronidazole 0.4g qid Drug: Clarithromycin 0.5g bid Drug: Levofloxacin 0.5g qd Drug: Amoxicillin 1g bid 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: Bismuth potassium citrate 0.6g bid Drug: Metronidazole 0.4g qid Drug: Clarithromycin 0.5g bid Drug: Levofloxacin 0.5g qd Drug: Amoxicillin 1g bid 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

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: Bismuth potassium citrate

0.6g bid

Drug: Metronidazole

0.4g qid

Drug: Clarithromycin

0.5g bid

Drug: Levofloxacin

0.5g qd

Drug: Amoxicillin

1g bid

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: Bismuth potassium citrate

0.6g bid

Drug: Metronidazole

0.4g qid

Drug: Clarithromycin

0.5g bid

Drug: Levofloxacin

0.5g qd

Drug: Amoxicillin

1g bid

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

Outcome Measures

Primary Outcome Measures

Eradication rate of Helicobacter pylori [6 weeks]
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 [6 weeks]
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 [6 weeks]
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.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai	China	200000
2	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032
3	Huashan Hospital, Fudan University	Shanghai	Shanghai	China	200040