14-Day Antimicrobial Susceptibility Testing Guided Therapy Versus Personal Medication History Guided Therapy as a Rescue Treatment of Helicobacter Pylori Infection-A Randomized Controlled Trail
Overview
- Phase
- Phase 4
- Intervention
- susceptibility guided therapy
- Conditions
- Helicobacter Pylori Infection
- Sponsor
- Shandong University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Eradication rates in 2 groups
- Last Updated
- 5 years ago
Overview
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.
Investigators
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University
Eligibility Criteria
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.
Arms & Interventions
Antimicrobial susceptibility testing guided therapy
14d bismuth quadruple therapy based on susceptibility test.
Intervention: susceptibility guided therapy
Personal medication history guided therapy
14d bismuth quadruple therapy based on previous medication history.
Intervention: personal medication history guided therapy
Salvage therapy for negative culture
14d bismuth quadruple therapy based on previous medication history.
Intervention: personal medication history guided therapy
Salvage therapy for failed eradication
14d bismuth quadruple therapy for salvage treatment.
Intervention: salvage treatment for failed eradication
Outcomes
Primary Outcomes
Eradication rates in 2 groups
Time Frame: 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 Outcomes
- The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.(6 months)