Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the Rescue Treatment of Helicobacter Pylori Infection

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: susceptibility guided therapy; Drug: personal medication history guided therapy; Drug: salvage treatment for failed eradication

• Registration Number: NCT03565484
• Lead Sponsor: Shandong University

Brief Summary

The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day personal medication history guided therapy to tell which one has a better performance in both efficacy and safety.

Detailed Description

Helicobacter pylori (H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathology, especially non-cardiac gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill Helicobacter pylori, and reduce secondary drug resistance. But, there is a lack of high quality RCT to compare its efficacy with empirical regimen in the rescue treatment.

This study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Comparing this regimen with 14-day personal Medication History guided therapy to tell which one is better in clinic practice. Alterations in H.pylori assosicated dyspepsia and safety outcomes will also be evaluated.

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Study Start: 2019-01-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-10
• Last Update Posted: 2020-05-12
• Primary Completion: 2020-05-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients aged 18-70 with H. pylori infection. Patients with previous H. pylori eradication therapy for one or two times.

Exclusion Criteria

Patients unable or unwilling to receive gastroscopy; Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks; Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; Patients with known or suspected allergy to study medications; Currently pregnant or lactating; Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antimicrobial susceptibility testing guided therapy	susceptibility guided therapy	14d bismuth quadruple therapy based on susceptibility test.
Personal medication history guided therapy	personal medication history guided therapy	14d bismuth quadruple therapy based on previous medication history.
Salvage therapy for negative culture	personal medication history guided therapy	14d bismuth quadruple therapy based on previous medication history.
Salvage therapy for failed eradication	salvage treatment for failed eradication	14d bismuth quadruple therapy for salvage treatment.

Primary Outcome Measures

Name	Time	Method
Eradication rates in 2 groups	6 months	Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up.

Secondary Outcome Measures

Name	Time	Method
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.	6 months	Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.

Trial Locations

Locations (1)

Qilu hosipital; 🇨🇳 Jinan, Shandong, China