Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment

Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing
• Intervention / Treatment: Drug: Clarithromycin susceptibility dependant strategy; Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin; Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone; Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ); Drug: amoxicillin and furazolidone or amoxicillin and tetracycline; Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Ji'nan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University

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:

• Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

Exclusion Criteria:

• Enable to undergo upper endoscopy;
• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
• Known or suspected allergy to study medications;
• Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
• 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
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: clarithromycin dependant group; Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin. If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.	Drug: Clarithromycin susceptibility dependant strategy; Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin. If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.; Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin; all patients need these two drugs.; Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone; patients in the 6 antibiotics dependant group will use these intervention.
EXPERIMENTAL: 6 antibiotics dependant group; Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.	Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin; all patients need these two drugs.; Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ); Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
OTHER: salvage therapy for negative culture; when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily.	Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin; all patients need these two drugs.; Drug: amoxicillin and furazolidone or amoxicillin and tetracycline; salvage therapy for negative culture when the results of culture are negative
OTHER: salvage therapy for failed eradication; If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d.	Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin; all patients need these two drugs.; Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin; salvage therapy for failed eradication if failed with AST guided eradication therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eradication rates in 2 groups	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
the rate of improving dyspepsia symptoms after H. pylori eradication	6 months
the rate of adverse events happening	6 months
the rate of good compliance (take pills more than 90%)	5 months
difference of cost per patient for each eradication achieved in 2 groups	6 months

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Shandong Provincial Hospital; Liaocheng People's Hospital; Binzhou People's Hospital; General Hospital of Jinan Military Region

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2017
• Primary Completion (ANTICIPATED): September 1, 2017
• Study Completion (ANTICIPATED): September 1, 2017

Study Registration Dates

• First Submitted: December 4, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (ESTIMATE): December 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 23, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Helicobacter Pylori Infection; Antimicrobial susceptibility testing (AST)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; 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; Cytochrome P-450 CYP1A2 Inhibitors; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Metronidazole; Anti-Bacterial Agents; Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin; Tinidazole; Bismuth; Tetracycline; Proton Pump Inhibitors; Furazolidone
• Other Study ID Numbers: 2016SDU-QILU-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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