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

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: salvage treatment for failed eradication; Drug: susceptibility guided therapy; Drug: personal medication history guided therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03565484

2017SDU-QILU-G004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

Antimicrobial susceptibility testing guided therapy

Experimental group

Description:

14d bismuth quadruple therapy based on susceptibility test.

Treatment:

Drug: susceptibility guided therapy

Personal medication history guided therapy

Experimental group

Description:

14d bismuth quadruple therapy based on previous medication history.

Treatment:

Drug: personal medication history guided therapy

Salvage therapy for negative culture

Other group

Description:

14d bismuth quadruple therapy based on previous medication history.

Treatment:

Drug: personal medication history guided therapy

Salvage therapy for failed eradication

Other group

Description:

14d bismuth quadruple therapy for salvage treatment.

Treatment:

Drug: salvage treatment for failed eradication