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

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing

Treatments: Drug: amoxicillin and furazolidone or amoxicillin and tetracycline; Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin; Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ); Drug: Clarithromycin susceptibility dependant strategy; Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone; Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

Study type: Interventional

Funder types: Other

Identifiers

NCT02988089

2016SDU-QILU-23

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 4 patient groups

clarithromycin dependant group

Experimental group

Description:

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.

Treatment:

Drug: Clarithromycin susceptibility dependant strategy

Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone

Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

6 antibiotics dependant group

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

Drug: amoxicillin and furazolidone or amoxicillin and tetracycline

Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

salvage therapy for failed eradication

Other group

Description:

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.

Treatment:

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

Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin