Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H. Pylori Infection
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|ClinicalTrials.gov Identifier: NCT03361267|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection Compliance, Patient Drug Resistance Antibiotics||Diagnostic Test: Helicobacter pylori PCR test Diagnostic Test: CLO test||Not Applicable|
In order to be eligible for first-line H. pylori eradication therapy, at least 80% of eradication rate should be achieved by intention to treat (ITT) analysis. However, the triple therapy (PPI, clarithromycin, amoxicillin) is losing 1st-line therapy because of increasing antibiotic resistance. The most common cause of failure in triple therapy is clarithromycin resistance.
In the past, clarithromycin resistance was rarely observed in Korea, but the resistance rate has increased rapidly during the last 10 years, up to 37.3%.
As an alternative, Korean guidelines of Helicobacter pylori eradication in 2013 recommend that bismuth-containing antibiotics (not containing clarithromycin) should be considered in areas with high clarithromycin resistance as in Korea. However, there is a lack of research on the efficacy of bismuth-containing quadruple therapy as a 1st-line therapy. The aim of this prospectivce randomized study is to investingate the efficacy, conpliance, adverse events and cost-effectiveness between bismuth containing quadruple therapy and tailored therapy in areas with high clarithromycin resistance
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Bismuth Containing Quadruple Therapy and Clarithromycin Susceptibility-based Tailored Therapy for Helicobacter Pylori First-line Eradication|
|Estimated Study Start Date :||December 30, 2017|
|Estimated Primary Completion Date :||June 28, 2018|
|Estimated Study Completion Date :||June 28, 2018|
Active Comparator: Bismuth containing quadruple therapy
If CLO test is positive, Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 5100 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) are prescribed for 7 days If CLO test is negative, no intervention is needed
Diagnostic Test: CLO test
CLO test : negative --> drop out CLO test : postive --> bismuth containing quadruple therapy
Experimental: tailored therapy
If H. pylori PCR is negative, no intervention is needed If H. pylori PCR is positive and mutation is negative, triple regimen (rabeprazole 20 mg bid, amoxacillin 1000 mg bid, clarithromycin 500mg bid) are prescribed for 7 days is given If H. pylori PCR is positive and mutation is positive, Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 5100 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) are prescribed for 7 days is given
Diagnostic Test: Helicobacter pylori PCR test
Clarithromycin resistance (-) Triple therapy (rabeprazole 20 mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid) for 7 days Clarithromycin resistance (+) Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 500 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) for 7 days
- Helicobacter pylori eradication rate [ Time Frame: Six weeks after completion of therapy ]
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test or CLO test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
or negative from CLO test
- Rate of adverse effects [ Time Frame: within 7 days after completion of therapy ]During the 7-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. 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).
- Compliance rate [ Time Frame: within 7 days after completion of therapy ]Compliance was deﬁned as poor when they had taken less than 80% of the total medication.
- Medical cost [ Time Frame: two months after completion of therapy ] ]Summation of diagnostic fee, cost of medication and 2-line therapy cost if the 1st line therapy fails
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361267
|Contact: Byoung Wook Bang, M.D. phDfirstname.lastname@example.org|
|Contact: Hyung Kil Kim, M.D. phDemail@example.com|
|Korea, Republic of|
|Inha University Hospital||Recruiting|
|Incheon, Korea, Republic of, 22332|
|Contact: Byoung WooK Bang, M.D. phD +82-32-890-2548 firstname.lastname@example.org|