Tailored Juice-guided Eradication Therapy
NCT04061447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182
Last updated 2019-08-20
Summary
In this study, the investigators aim to investigate the efficacy of tailored anti-microbial susceptibility guided-therapy via gastric juice PCR, compared with empirical standard triple therapy.
Conditions
- Helicobacter Pylori Infection
Interventions
- DRUG
-
susceptibility-guided therapy
rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days.
- DRUG
-
empirical clarithromycin-based triple therapy
The eradication regimen was based on the susceptibility results of gastric PCR. If clarithromycin was sensitive, the regimen contained rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days. If clarithromycin was resistant and levofloxacin was sensitive, the regimen was rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and levofloxacin 500mg QD for seven days. If clarithromycin and levofloxacin were both resistant, the regimen was either reverse-hybrid therapy (rabeprazole 20mg B.I.D x 14 days, amoxicillin 1000mg B.I.D, x 14 days, clarithromycin 500mg B.I.D for 7 days, and metronidazole 500mg B.I.D for 7 days) or high dose dual therapy (rabeprazole 20mg Q.I.D and amoxicillin 1000mg Q.I.D for 14 days). Owing to this open design, either reverse-hybrid therapy or high dose dual therapy was chosen by doctors' preference.
Sponsors & Collaborators
-
Kaohsiung Medical University
lead OTHER
Principal Investigators
-
Deng-Chyang Wu, MD, PHD · Kaohsiung Medical University
-
Chao-Hung Kuo, MD, PHD · Kaohsiung Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-05
- Primary Completion
- 2019-05-31
- Completion
- 2019-07-31
Countries
- Taiwan
Study Locations
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