Clinical trial NCT03361267: Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H. Pylori Infection
Official title: Comparison of Bismuth Containing Quadruple Therapy and Clarithromycin Susceptibility-based Tailored Therapy for Helicobacter Pylori First-line Eradication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Compliance, Patient
Drug Resistance
Antibiotics
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: within 7 days after completion of therapy
measure: Compliance rate
timeFrame: within 7 days after completion of therapy
measure: Medical cost
timeFrame: two months after completion of therapy ]
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References: