NCT05250050

Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 388 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-25
• Primary completion: 2022-12-30
• Completion: 2023-03-01
• First posted: 2022-02-22
• Last updated: 2022-03-18

Locations

3 sites across 1 country: China