Antimicrobial Susceptibility Test, Eradication, Helicobacter Pylori, Therapeutic Duration
Conditions
Brief summary
Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies. However, due to the increasing resistance rates to antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy for persistent H. pylori infection is becoming a grand challenge the investigators have to face.
Interventions
OTHER7-day triple regimen guided by AST
Patients in this group will receive a 7-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
OTHER10-day triple regimen guided by AST
Patients in this group will receive a 10-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
OTHER14-day triple regimen guided by AST
Patients in this group will receive a 14-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients require upper endoscopy owing to persistent H. pylori infection despite one or more treatment attempts.
Exclusion criteria
* Age younger than 18 years; * Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; * Known or suspected allergy to study medications; * Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in intention-to-treat (ITT) analysis. | 9 months |
| The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in per-protocol (PP) analysis. | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| the rate of improving dyspepsia symptoms after H. pylori eradication | 9 months |
| the rate of adverse events happening | 9 months |
Contacts
Primary ContactLi Yanqing, MD, PhD
Outcome results
None listed