Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Amoxicillin; Drug: Metronidazole; Drug: Levofloxacin; Drug: Clarithromycin; Drug: Bismuth potassium citrate; Drug: Tetracycline; Drug: Esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05250050

B2021-831

Details and patient eligibility

About

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.

Full 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.

Enrollment: 388 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

388 participants in 3 patient groups

Genotypic resistance guided therapy

Experimental group

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.

Treatment:

Drug: Bismuth potassium citrate

Drug: Metronidazole

Drug: Clarithromycin

Drug: Levofloxacin

Drug: Tetracycline

Drug: Amoxicillin

Drug: Esomeprazole

Phenotypic resistance guided therapy

Experimental group

Description:

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.

Treatment:

Drug: Bismuth potassium citrate

Drug: Metronidazole

Drug: Clarithromycin

Drug: Levofloxacin

Drug: Tetracycline

Drug: Amoxicillin

Drug: Esomeprazole

Empiric therapy

Active Comparator group

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

Treatment:

Drug: Bismuth potassium citrate

Drug: Metronidazole

Drug: Tetracycline

Drug: Amoxicillin

Drug: Esomeprazole