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

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparison of Bismuth Containing Quadruple Therapy and Clarithromycin Susceptibility-based Tailored Therapy for Helicobacter Pylori First-line Eradication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03361267
• Other study ID #: Inha helicobacter study
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2017
• Last updated: December 10, 2017
• Start date: December 30, 2017
• Est. completion date: June 28, 2018

Study information

• Verified date: December 2017
• Source: Inha University Hospital
• Contact: Byoung Wook Bang, M.D. phD
• Phone: +82-32-890-2548
• Email: bangbu[@]inha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotics
• Compliance, Patient
• Drug Resistance
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

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
CLO test : negative --> drop out CLO test : postive --> bismuth containing quadruple therapy

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six weeks after completion of therapy
Secondary	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).	within 7 days after completion of therapy
Secondary	Compliance rate	Compliance was de?ned as poor when they had taken less than 80% of the total medication.	within 7 days after completion of therapy
Secondary	Medical cost	Summation of diagnostic fee, cost of medication and 2-line therapy cost if the 1st line therapy fails	two months after completion of therapy ]