A Phase 4 interventional study of esomeprazole and bismuth Potassium Citrate in Helicobacter Pylori Infection, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
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With increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. This study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with Helicobacter pylori infection.
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.
Drug: esomeprazole · Drug: bismuth Potassium Citrate · Drug: amoxicillin · Drug: clarithromycin · Drug: metronidazole · Drug: levofloxacin
proton pump inhibitor
gastric mucosal protective drug with anti-H. pylori effect
antibiotic for H. pylori eradication
antibiotic for H. pylori eradication
antibiotic for H. pylori eradication
antibiotic for H. pylori eradication
Helicobacter pylori eradication rate
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).
Time frame: Six weeks after completion of therapy
Rate of adverse effects
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).
Time frame: Within 7 days after completion of therapy
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication.
Time frame: Within 7 days after completion of therapy
Medical cost per patient of tailored therapy
Time frame: Two months after completion of therapy
Plan to share: No
Ran from Jan 2018 to primary completion in Jul 2018, 6 months.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Esomeprazole · Bismuth · Amoxicillin · Clarithromycin · Metronidazole · Levofloxacin
Shanghai Jiao Tong University School of Medicine →