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

NCT ID: NCT03571230

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-01-30

Brief Summary

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.

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.

Conditions

Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)

Intervention Type: DRUG

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.

one proton pump inhibitor(PPI)

Intervention Type: DRUG

All the patients need this drug.

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.

Group Type: EXPERIMENTAL

two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)

Intervention Type: DRUG

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.

one proton pump inhibitor(PPI)

Intervention Type: DRUG

All the patients need this drug.

Colloidal Bismuth Pectin

Intervention Type: DRUG

All the patients treated with 14-day bismuth-based quadruple therapy need this drug.

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.

Group Type: OTHER

two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)

Intervention Type: DRUG

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.

one proton pump inhibitor(PPI)

Intervention Type: DRUG

All the patients need this drug.

Colloidal Bismuth Pectin

Intervention Type: DRUG

All the patients treated with 14-day bismuth-based quadruple therapy need this drug.

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.

Group Type: OTHER

one proton pump inhibitor(PPI)

Intervention Type: DRUG

All the patients need this drug.

Colloidal Bismuth Pectin

Intervention Type: DRUG

All the patients treated with 14-day bismuth-based quadruple therapy need this drug.

two antibiotics for failed eradication(tetracyclin,furazolidone)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

one proton pump inhibitor(PPI)

All the patients need this drug.

Intervention Type: DRUG

Colloidal Bismuth Pectin

All the patients treated with 14-day bismuth-based quadruple therapy need this drug.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

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

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

director of Qilu Hospital gastroenterology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuli Zuo, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Xiuli Zuo

Jinan, Shandong, China

Countries

China

Central Contacts

Xiuli Zuo, PhD,MD

Role: CONTACT

zuoxiuli@sina.com

15588818685 ext. 053188369277

Facility Contacts

Xiuli Zuo, PhD,MD

Role: primary

zuoxiuli@sina.com

15588818685 ext. 053188369277

Other Identifiers

2017SDU-QILU-G003

Identifier Type: -

Identifier Source: org_study_id