Antimicrobial Susceptibility Testing, Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter Pylori Infection, Antimicrobial susceptibility testing (AST)
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.
Interventions
DRUGClarithromycin 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.
DRUG2 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.
DRUGproton pump inhibitor (PPI) and Colloidal Bismuth Pectin
all patients need these two drugs.
DRUGamoxicillin and clarithromycin or amoxicillin and furazolidone
patients in the 6 antibiotics dependant group will use these intervention.
DRUGamoxicillin and furazolidone or amoxicillin and tetracycline
salvage therapy for negative culture when the results of culture are negative
DRUGamoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin
salvage therapy for failed eradication if failed with AST guided eradication therapy
Sponsors
Shandong Provincial Hospital
General Hospital of Jinan Military Region
Binzhou People's Hospital
Liaocheng People's Hospital
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication rates in 2 groups | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactLi Yanqing, MD, PhD
Outcome results
None listed