A Phase 4 interventional study of susceptibility guided therapy and personal medication history guided therapy in Helicobacter Pylori Infection, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-12.
Sponsored by Shandong University · Phase 4, Interventional, and Treatment
The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day personal medication history guided therapy to tell which one has a better performance in both efficacy and safety.
Helicobacter pylori (H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathology, especially non-cardiac gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill Helicobacter pylori, and reduce secondary drug resistance. But, there is a lack of high quality RCT to compare its efficacy with empirical regimen in the rescue treatment.
This study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Comparing this regimen with 14-day personal Medication History guided therapy to tell which one is better in clinic practice. Alterations in H.pylori assosicated dyspepsia and safety outcomes will also be evaluated.
Shandong University is the lead sponsor of 291 studies on the registry; 59 are open to participants now.
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Patients aged 18-70 with H. pylori infection. Patients with previous H. pylori eradication therapy for one or two times.
Exclusion Criteria:
Patients unable or unwilling to receive gastroscopy; Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks; Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; Patients with known or suspected allergy to study medications; Currently pregnant or lactating; Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
14d bismuth quadruple therapy based on susceptibility test.
Drug: susceptibility guided therapy
14d bismuth quadruple therapy based on previous medication history.
Drug: personal medication history guided therapy
14d bismuth quadruple therapy based on previous medication history.
Drug: personal medication history guided therapy
14d bismuth quadruple therapy for salvage treatment.
Drug: salvage treatment for failed eradication
Patients will take a gastroscopy and 2 biopsies will be attained from antrum and gastric body for H.pylori culture and antimicrobial susceptibility testing (AST). The susceptibility of amoxicillin, clarithromycin, metronidazole, levofloxacin, furazolidone and tetracycline will be tested.Then patients with positive culture will be treated with a 14-day quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, and two sensitive antibiotics determined by AST. Dose of two sensitive antibiotics are listed as follows : amoxicillin 1000mg bid, clarithromycin 500mg bid, tinidazole 500mg tid, levofloxacin 500mg qd, furazolidone 100mg bid, tetracycline 500mg qid.
Patients will be treated with a 14-day emprical tailored quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid， colloidal bismuth pectin 200mg bid and two antibiotics based on personal medication history. If the patient doesn't have levofloxacin history, he will be treated with amoxicillin 1000mg bid plus levofloxacin 500mg bid. Otherwise, he will be treated with amoxicillin 1000mg bid and furazolidone 100mg bid.
If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, tetracycline 500mg qid and furazolidone 100mg bid.
Eradication rates in 2 groups
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up.
Time frame: 6 months
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.
Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.
Time frame: 6 months
The rate of adverse events happening
Similarly, adverse events will also be measured by the Likert scale.
Time frame: 6 months
The rate of good compliance
Patients taken over 80% of drugs are considered to have a good compliance.
Time frame: 6 months
Difference of cost per patient for each eradication achieved in two groups
Time frame: 6 months
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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