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Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection

RecruitingPhase 4Ages 20 Years - anyAllNational Taiwan University Hospital
NCT05332444 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The prevalence of H. pylori antibiotic resistance has reached an alarming level worldwide. Antibiotic stewardship programs should be urgently developed and implemented. However, H. pylori antimicrobial susceptibility testing (AST) is rarely offered, making local resistance patterns not easily available. Guideline-recommended empiric therapies (GR-ET) may no longer reliably achieve high cure rate in the era of increasing antibiotic resistance. susceptibility-guided tailored therapy (SG-TT) may be a good choice to solve this problem. The aims of this study are: 1. to compare the efficacy of SG-TT with GR-ET as rescue regimens for H. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Patients, aged \>= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens. Exclusion Criteria: 1. pregnant or nursing woman; 2. serious concomitant illness and malignant tumor of any kind; 3. history of hypersensitivity to test drugs๏ผ› 4. serious bleeding during the course of this ulcer; 5. previous gastric surgery; 6. receiving bismuth salts, PPIs, or antibiotics in the previous month.
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What it tests

  • susceptibility-guided tailored therapy (Group A)
  • guidelines-recommended empiric therapy (Group B)
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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