An interventional study of Helicobacter pylori PCR test and CLO test in Helicobacter Pylori Infection, Compliance, Patient and Drug Resistance, sponsored by Inha University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-12.
Sponsored by Inha University Hospital · Not applicable, Interventional, and Treatment
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As the antibiotic resistance increases, the eradication rate of triple therapy is decreasing. Recent guideline recommend the use of bismuth-containing quadruple therapy in areas where clarithromycin resistance is greater than 15%. However, the ideal treatment would be the tailored therapy which choose the antibiotics depending on the antibiotic resistance. This study compared the eradication rates, safety and complicance of tailored therapy compared with empirical bismuth quadruple therapy in the naive patients with H. pylori infection.
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
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
This study's planned enrollment of 300 is above the median of 116 across 527 interventional studies indexed under Patient Compliance.
Browse Patient Compliance studies →Inha University Hospital is the lead sponsor of 37 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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.
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.
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
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
CLO test : negative --\> drop out CLO test : postive --\> bismuth containing quadruple therapy
Helicobacter pylori eradication rate
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
Time frame: Six weeks after completion of therapy
Rate of adverse effects
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).
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
Summation of diagnostic fee, cost of medication and 2-line therapy cost if the 1st line therapy fails
Time frame: two months after completion of therapy ]
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2017; primary completion for Jun 2018, 5 months later.
Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 5 months is below that.
Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Inha University Hospital