Efficacy of Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment：a Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Esomeprazole
- Conditions
- Helicobacter Pylori Infection
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 382
- Locations
- 5
- Primary Endpoint
- Helicobacter pylori eradication rate
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.
Investigators
Hong Lu, MD
Doctor
Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
- •Ability and willingness to participate in the study and to sign and give informed consent
- •confirmed H. pylori infection
Exclusion Criteria
- •Previous H. pylori eradication therapy
- •Less than 18 years old
- •With history of H. pylori infection treatment
- •With previous gastric surgery
- •Major systemic diseases
- •Pregnancy or lactation
- •Allergy to any of the study drugs
- •Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Arms & Interventions
Tailored therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Esomeprazole
Tailored therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Bismuth Potassium Citrate
Tailored therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Amoxicillin
Tailored therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Clarithromycin
Tailored therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Metronidazole
Tailored therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Intervention: Levofloxacin
Empiric therapy
give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days
Intervention: Esomeprazole
Empiric therapy
give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days
Intervention: Bismuth Potassium Citrate
Empiric therapy
give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days
Intervention: Amoxicillin
Empiric therapy
give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days
Intervention: Metronidazole
Outcomes
Primary Outcomes
Helicobacter pylori eradication rate
Time Frame: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
Secondary Outcomes
- Compliance rate(within 7 days after completion of therapy)
- Rate of adverse effects(within 7 days after completion of therapy)