Antibiotics, Compliance, Patient, Drug Resistance, Helicobacter Pylori Infection
Conditions
Brief summary
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.
Detailed description
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
Interventions
DIAGNOSTIC_TESTHelicobacter 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
DIAGNOSTIC_TESTCLO test
CLO test : negative --\> drop out CLO test : postive --\> bismuth containing quadruple therapy
Sponsors
Inha University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants with peptic ulcer, s/p ESD due to early gastric cancer/gastric adenoma, Maltoma * Ability and willingness to participate in the study and to sign and give informed consent * confirmed H. pylori infection
Exclusion criteria
* Previous H. pylori eradication therapy * Less than 18 years old * With history of H. pylori infection treatment * With previous gastric surgery * Major systemic diseases * Pregnancy or lactation * Allergy to any of the study drugs * Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse effects | 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 | 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 | two months after completion of therapy ] | Summation of diagnostic fee, cost of medication and 2-line therapy cost if the 1st line therapy fails |
Countries
South Korea
Contacts
Primary ContactByoung Wook Bang, M.D. phD
Backup ContactHyung Kil Kim, M.D. phD
Outcome results
None listed