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

NCT ID: NCT02988089

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2017-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Clarithromycin susceptibility dependant strategy

Intervention Type: 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.

proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

Intervention Type: DRUG

all patients need these two drugs.

amoxicillin and clarithromycin or amoxicillin and furazolidone

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

Intervention Type: DRUG

all patients need these two drugs.

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.

Group Type: OTHER

proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

Intervention Type: DRUG

all patients need these two drugs.

amoxicillin and furazolidone or amoxicillin and tetracycline

Intervention Type: DRUG

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

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.

Group Type: OTHER

proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

Intervention Type: DRUG

all patients need these two drugs.

amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

all patients need these two drugs.

Intervention Type: DRUG

amoxicillin and clarithromycin or amoxicillin and furazolidone

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

Intervention Type: DRUG

amoxicillin and furazolidone or amoxicillin and tetracycline

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

Intervention Type: DRUG

amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

General Hospital of Jinan Military Region

UNKNOWN

Sponsor Role: collaborator

Binzhou People's Hospital

OTHER

Sponsor Role: collaborator

Liaocheng People's Hospital

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Vice president of Qilu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Yanqing, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Department of Gastroenterology, Qilu Hospital, Shandong University

Ji'nan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Yanqing, MD, PhD

Role: CONTACT

liyanqing@sdu.edu.cn

86-531-82169236

Facility Contacts

Yanqing Li, MD, PhD

Role: primary

liyanqing@sdu.edu.cn

86-531-82169236

Yanqing Li, MD, PhD

Role: backup

liyanqing@sdu.edu.cn

86-0531-82169236

Other Identifiers

2016SDU-QILU-23

Identifier Type: -

Identifier Source: org_study_id