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

NCT02988089 | Unknown Phase 4 DMC

• 1 other identifier: 2016SDU-QILU-23
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing

Keywords

Helicobacter Pylori Infection; Antimicrobial susceptibility testing (AST)

Outcome Measures

Primary Outcomes (1)

• Eradication rates in 2 groups

  6 months

Secondary Outcomes (4)

• 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

Study Arms (4)

clarithromycin dependant group

EXPERIMENTAL

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; Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin; Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone

6 antibiotics dependant group

EXPERIMENTAL

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: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ); Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

salvage therapy for negative culture

OTHER

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; Drug: amoxicillin and furazolidone or amoxicillin and tetracycline

salvage therapy for failed eradication

OTHER

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; Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin

Interventions

Clarithromycin susceptibility dependant strategy DRUG

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.

clarithromycin dependant group

2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ) DRUG

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.

6 antibiotics dependant group

proton pump inhibitor (PPI) and Colloidal Bismuth Pectin DRUG

all patients need these two drugs.

6 antibiotics dependant group; clarithromycin dependant group; salvage therapy for failed eradication; salvage therapy for negative culture

amoxicillin and clarithromycin or amoxicillin and furazolidone DRUG

patients in the 6 antibiotics dependant group will use these intervention.

clarithromycin dependant group

amoxicillin and furazolidone or amoxicillin and tetracycline DRUG

salvage therapy for negative culture when the results of culture are negative

salvage therapy for negative culture

amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin DRUG

salvage therapy for failed eradication if failed with AST guided eradication therapy

salvage therapy for failed eradication

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead
• Shandong Provincial Hospital: collaborator
• General Hospital of Jinan Military Region: collaborator
• Binzhou People's Hospital: collaborator
• Liaocheng People's Hospital: collaborator

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Ji'nan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Amoxicillin; Clarithromycin; Metronidazole; Tinidazole; Levofloxacin; Furazolidone; Tetracycline; Proton Pump Inhibitors

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Nitrofurans; Oxazolidinones; Oxazoles; Furans; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Li Yanqing, MD, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yanqing, MD, PhD

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: December 9, 2016
• Study Start: April 20, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)