10-Day Antimicrobial Susceptibility Testing Guided Triple Therapy Versus 14-Day Empirical Tailored Therapy for the First-line Treatment of Helicobacter Pylori Infection-A Randomized Controlled Trail
Sponsor study identifier
interventional
400
1 country
1
Study Start
July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2020
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 18, 2018
Actual (reported)June 27, 2018
Actual (reported)July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 30, 2020
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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 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.
6 months
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.
6 months
The rate of adverse events happening
6 months
The rate of good compliance
6 months
Difference of cost per patient for each eradication achieved in two groups
6 months
Patients in this group will receive a 10-day triple therapy for the Helicobacter pylori eradication. The regimen contains one proton pump inhibitor and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 10d 2.two sensitive antibiotics: amoxicillin 1000mg bid for 10d, clarithromycin 500mg bid for 10d, metronidazole 500mg tid for 10d, tinidazole 500mg tid for 10d, levofloxacin 500mg qd for 10d, furazolidone 100mg bid for 10d, tetracycline 750mg bid for 10d.
Patients in this group will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.
Patients will receive a 10-day triple therapy for the H.pylori eradication. The regimen contains one PPI and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
Xiuli Zuo
Jinan, Shandong, China
Xiuli Zuo, PhD,MD
Qilu Hospital of Shandong University
First Submitted
June 18, 2018
First Posted
June 27, 2018
Study Start
July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin
When the culture results are negative, patients will receive 14-day empirical tailored therapy based on personal medication history. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.
If patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics for rescue therapy: tetracycline 750mg bid and furazolidone 100mg bid for 14d.
Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.
All the patients need this drug.
All the patients treated with 14-day bismuth-based quadruple therapy need this drug.
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 one PPI, Colloidal Bismuth Pectin, tetracycline and furazolidone.
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Primary Completion
December 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 27, 2018
Record last verified: 2018-06
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