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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
Sponsor:
Information provided by (Responsible Party):
Inha University Hospital

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.

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

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Byoung Wook Bang, M.D. phD +82-32-890-2548 bangbu@inha.ac.kr
Contact: Hyung Kil Kim, M.D. phD +82-32-890-2548 kimhg@inha.ac.kr

Locations
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Korea, Republic of
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 22332
Contact: Byoung WooK Bang, M.D. phD    +82-32-890-2548    bangbu@inha.ac.kr   
Sponsors and Collaborators
Inha University Hospital

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Responsible Party: Inha University Hospital
ClinicalTrials.gov Identifier: NCT03361267     History of Changes
Other Study ID Numbers: Inha helicobacter study
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gram-Negative Bacterial Infections
Bacterial Infections
Rabeprazole
Infection
Helicobacter Infections
Metronidazole
Clarithromycin
Tetracycline
Bismuth
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Antacids