NCT02988089

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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	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.
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.
DRUG	amoxicillin and furazolidone or amoxicillin and tetracycline	salvage therapy for negative culture when the results of culture are negative
DRUG	amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin	salvage therapy for failed eradication if failed with AST guided eradication therapy

Timeline

• Start date: 2017-04-20
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-12-09
• Last updated: 2017-04-25

Locations

1 site across 1 country: China