A Phase 4 interventional study of esomeprazole, amoxicillin, furazolidone，tetracycline 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 2020-02-21.
Sponsored by Shandong University · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.
Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Patients will receive a 14-day concomitant therapy containing esomeprazole, amoxicillin, tetracycline and furazolidone.
Drug: esomeprazole, amoxicillin, furazolidone，tetracycline
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day concomitant therapy containing esomeprazole 40mg bid, amoxicillin 1000mg bid , furazolidone 100mg bid and tetracycline 500mg qid.
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 the 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 rate 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
Changes of dyspepsia symptoms after Helicobacter pylori eradication
A list of dyspepsia symptoms will be recorded. Difference of dyspepsia symptoms before and after the therapy will be compared.
Time frame: 6 months
The rate of good compliance
Patients taken over 90% of drugs are considered to have a good compliance.
Time frame: 6 months
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Shandong University