Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H. Pylori Infection

Inha University Hospital

Status: Unknown

Conditions: Antibiotics; Helicobacter Pylori Infection; Drug Resistance; Compliance, Patient

Treatments: Diagnostic Test: Helicobacter pylori PCR test; Diagnostic Test: CLO test

Study type: Interventional

Funder types: Other

Identifiers

NCT03361267

Inha helicobacter study

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Bismuth containing quadruple therapy

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: CLO test

tailored therapy

Experimental group

Description:

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

Treatment:

Diagnostic Test: Helicobacter pylori PCR test