A Phase 4 interventional study of two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline) and one proton pump inhibitor, colloidal bismuth pectin in Helicobacter Pylori Infection, sponsored by Shandong University. Completed 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 empirical therapy according to personal medication history.
Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been classified as the first risk factor of 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 H.pylori, and reduce secondary drug resistance. However, there is a lack of high quality RCT to evaluate its efficacy in the rescue treatment of Helicobacter infection.
The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 420 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Patients in this group will receive a 14-day quadruple therapy for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin, and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d, 2.Colloidal Bismuth Pectin 200mg bid for 14d, 3.two sensitive antibiotics: amoxicillin 1000mg bid for 14d, clarithromycin 500mg bid for 14d, metronidazole 500mg tid for 14d, tinidazole 500mg tid for 14d, levofloxacin 500mg qd for 14d, furazolidone 100mg bid for 14d, tetracycline 500mg qid for 14d.
Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline) · Drug: one proton pump inhibitor, colloidal bismuth pectin
Patients in this group will receive a 14-day quadruple therapy based on personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics chosen according to medication history. If the patient hasn't been treated with levofloxacin in the previous eradication regimen, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone. Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and levofloxacin 500mg qd for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.
Drug: one proton pump inhibitor, colloidal bismuth pectin · Drug: two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)
Patients will receive a 14-day quadruple therapy for the H.pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
All patients need these two drugs.
Patients will receive a 14-day quadruple therapy according to personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient hasn't been treated with levofloxacin previously, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone.
Eradication rates
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Time frame: 6 months
The rates of adverse events happening
Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.
Time frame: 6 months
The rates of improving dyspepsia symptoms after helicobacter pylori eradication.
Dyspepsia symptoms will also be measured using a 8-point Likert scale.be compared. Common adverse events will be measured using a 8-point Likert scale. Patients rate their symptoms from 0 (none) to 8 (severe) before and after the treatment process.
Time frame: 6 months
The rates of good compliance.
Patients taken over 90% of drugs are considered to have a good compliance.
Time frame: 6 months
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Shandong University