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 2019-12-10.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
Increasing drug resistance presents a significant challenge to the efficacies of common empiric eradication regimens for Helicobacter pylori treatment in the mainland of China. Tailored therapy may be the best choice to achieve good efficacy, especially in patients with penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored therapy for Helicobacter pylori treatment in the patients with penicillin allergy.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 112 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
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Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
Drug: Esomeprazole · Drug: Bismuth Potassium Citrate · Drug: Clarithromycin · Drug: Metronidazole · Drug: Levofloxacin · Drug: Tetracycline
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
Plan to share: No
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine