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

• ClinicalTrials.gov Identifier: NCT03361267
• Recruitment Status: Unknown
• First Posted: December 4, 2017
• Last Update Posted: December 12, 2017
• Sponsor: Inha University Hospital
• Information provided by (Responsible Party): Inha University Hospital

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

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

More Information

• Responsible Party: Inha University Hospital
• ClinicalTrials.gov Identifier: NCT03361267
• Other Study ID Numbers: Inha helicobacter study
• First Posted: December 4, 2017
• Last Update Posted: December 12, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Infections