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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03565484
• Other study ID #: 2017SDU-QILU-G004
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: Shandong University
• Contact: Xiuli Zuo, MD,PhD
• Phone: 15588818685
• Email: zuoxiuli[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Disease Susceptibility
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• susceptibility guided therapy
Patients will take a gastroscopy and 2 biopsies will be attained from antrum and gastric body for H.pylori culture and antimicrobial susceptibility testing (AST). The susceptibility of amoxicillin, clarithromycin, metronidazole, levofloxacin, furazolidone and tetracycline will be tested.Then patients with positive culture will be treated with a 14-day quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, and two sensitive antibiotics determined by AST. Dose of two sensitive antibiotics are listed as follows : amoxicillin 1000mg bid, clarithromycin 500mg bid, tinidazole 500mg tid, levofloxacin 500mg qd, furazolidone 100mg bid, tetracycline 500mg qid.
• personal medication history guided therapy
Patients will be treated with a 14-day emprical tailored quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid and two antibiotics based on personal medication history. If the patient doesn't have levofloxacin history, he will be treated with amoxicillin 1000mg bid plus levofloxacin 500mg bid. Otherwise, he will be treated with amoxicillin 1000mg bid and furazolidone 100mg bid.
• salvage treatment for failed eradication
If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, tetracycline 500mg qid and furazolidone 100mg bid.

Locations

Country	Name	City	State
China	Qilu hosipital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The rate of adverse events happening	Similarly, adverse events will also be measured by the Likert scale.	6 months
Other	The rate of good compliance	Patients taken over 80% of drugs are considered to have a good compliance.	6 months
Other	Difference of cost per patient for each eradication achieved in two groups		6 months
Primary	Eradication rates in 2 groups	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.	6 months
Secondary	The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.	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.	6 months