Clinical trial NCT05250050: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori
timeFrame: 6 weeks
Secondary outcomes:
measure: Eradication rate of Helicobacter pylori resistant strains
timeFrame: 6 weeks
measure: Eradication rate of Helicobacter pylori susceptible strains
timeFrame: 6 weeks
Other outcomes:
measure: Adherence rate
timeFrame: 2 weeks during therapy
measure: Frequency of adverse events
timeFrame: 2 weeks during therapy
measure: Average cost of each group
timeFrame: 6 weeks
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Hong Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: