Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.

10-Day Antimicrobial Susceptibility Testing Guided Triple Therapy Versus 14-Day Empirical Tailored Therapy for the First-line Treatment of Helicobacter Pylori Infection-A Randomized Controlled Trail

The purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing
• Intervention / Treatment: Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline); Drug: one proton pump inhibitor(PPI); Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone); Drug: Colloidal Bismuth Pectin; Drug: two antibiotics for failed eradication(tetracyclin,furazolidone)

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 pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies. 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 first-line treatment.

Our study aims to assess the efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection. Comparing this regimen with 14-day Empirical Tailored Therapy to tell which one is better in clinic practice. We also want to find whether the 10-day antimicrobial susceptibility test guided triple therapy has less intestinal dysbacteriosis with a shorter duration.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiuli Zuo, PhD,MD; Phone Number: 053188369277 15588818685; Email: zuoxiuli@sina.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Xiuli Zuo
      • Contact: Xiuli Zuo, PhD,MD; Phone Number: 053188369277 15588818685; Email: zuoxiuli@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 18-70 with H. pylori infection.

Exclusion Criteria:

• Patients with previous H. pylori eradication therapy;
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antimicrobial susceptibility testing guided therapy; Patients in this group will receive a 10-day triple therapy for the Helicobacter pylori eradication. The regimen contains one proton pump inhibitor and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 10d 2.two sensitive antibiotics: amoxicillin 1000mg bid for 10d, clarithromycin 500mg bid for 10d, metronidazole 500mg tid for 10d, tinidazole 500mg tid for 10d, levofloxacin 500mg qd for 10d, furazolidone 100mg bid for 10d, tetracycline 750mg bid for 10d.	Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline); Patients will receive a 10-day triple therapy for the H.pylori eradication. The regimen contains one PPI and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.; Drug: one proton pump inhibitor(PPI); All the patients need this drug.
Experimental: Empirical tailored therapy; Patients in this group will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.	Drug: one proton pump inhibitor(PPI); All the patients need this drug.; Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone); Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.; Drug: Colloidal Bismuth Pectin; All the patients treated with 14-day bismuth-based quadruple therapy need this drug.
Other: Salvage therapy for negative culture; When the culture results are negative, patients will receive 14-day empirical tailored therapy based on personal medication history. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.	Drug: one proton pump inhibitor(PPI); All the patients need this drug.; Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone); Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.; Drug: Colloidal Bismuth Pectin; All the patients treated with 14-day bismuth-based quadruple therapy need this drug.
Other: Salvage therapy for failed eradication; If patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics for rescue therapy: tetracycline 750mg bid and furazolidone 100mg bid for 14d.	Drug: one proton pump inhibitor(PPI); All the patients need this drug.; Drug: Colloidal Bismuth Pectin; All the patients treated with 14-day bismuth-based quadruple therapy need this drug.; Drug: two antibiotics for failed eradication(tetracyclin,furazolidone); 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 one PPI, Colloidal Bismuth Pectin, tetracycline and furazolidone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of good compliance	Patients taken over 90% of drugs are considered to have a good compliance.	6 months
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
The rate of adverse events happening	Similarly, adverse events will also be measured by the Likert scale.	6 months
Difference of cost per patient for each eradication achieved in two groups		6 months

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Xiuli Zuo, PhD,MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): January 30, 2020

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Helicobacter Pylori Infection; Antimicrobial Susceptibility testing(AST)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Susceptibility; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Alkylating Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Monoamine Oxidase Inhibitors; Antitubercular Agents; Cytochrome P-450 CYP1A2 Inhibitors; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Metronidazole; Anti-Bacterial Agents; Antibiotics, Antitubercular; Amoxicillin; Clarithromycin; Levofloxacin; Tinidazole; Bismuth; Tetracycline; Proton Pump Inhibitors; Furazolidone
• Other Study ID Numbers: 2017SDU-QILU-G003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No