Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250050
• Other study ID #: B2021-831
• Status: Recruiting
• Phase: Phase 4
• Start date: March 25, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Qi Chen, MD
• Phone: 86-17811921405
• Email: chenqimd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 388
• Est. completion date: March 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Esomeprazole
20mg bid
• Bismuth potassium citrate
0.6g bid
• Metronidazole
0.4g qid
• Clarithromycin
0.5g bid
• Levofloxacin
0.5g qd
• Amoxicillin
1g bid
• Tetracycline
0.5g qid

Locations

Country	Name	City	State
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Frequency of adverse events	Any possible adverse events during the 14-day treatment period were recorded.	2 weeks during therapy
Other	Average cost of each group	Average medical cost related to therapy and followup in each group	6 weeks
Primary	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	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
Secondary	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