Helicobacter Pylori Eradication According to DPO-PCR Methods (K-CREATE) Study)

Helicobacter Pylori Eradication According to DPO-PCR Methods: Duration of Triple Therapy and Bismuth Quadruple According to Clarithromycin Resistance Patterns (K-CREATE Study)

Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance have shown that regional resistance patterns to antibiotics such as clarithromycin are increasing. Recent studies show that examining genotype resistance is effective in eradication. Currently, dual priming oligonucleotide-polymerase chain reaction (DPO-PCR) is used to measure clarithromycin resistance. No study has compared the duration of eradication regimens according to DPO-PCR results. This study compares the eradication rate of 7-day triple therapy with 14-day triple therapy in clarithromycin susceptible strains from DPO-PCR. The investigators also aimed to compare the eradication rates of 7-day bismuth quadruple therapy with 14-day bismuth quadruple therapy from clarithromycin-resistant strains from DPO-PCR.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Duration of eradication regimen

Detailed Description

This is a multi-center study performed at 20 university hospitals. The study is composed of two phases. In phase I, patients with H. pylori infection are randomized to receive tailored or empirical therapy. The empirical therapy group is further randomized to receive either 7-day triple therapy or 14-day triple therapy. The tailored group is randomized to receive triple therapy if they are clarithromycin sensitive or bismuth quadruple therapy if they are clarithromycin resistant. Each group is further randomized to receive either seven or 14 days of treatment. The eradication rates and adverse events of each regimen will be investigated.

In phase 2, patients with H. pylori infection are randomized to receive tailored or empirial therapy. The empirical therapy group receives 14 days of triple therapy. The tailored therapy group receives 7-day triple therapy if they are clarithromycin sensitive and 7-day bismuth quadruple therapy if clarithromycin resistant.

• Study Type: Interventional
• Enrollment (Estimated): 1230
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joon S Kim, MD, PhD; Phone Number: 82322805057; Email: kijoons@nate.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Recruiting
    • Incheon St. Mary's Hospital
    • Contact: Byung-Wook Kim, Ph.D.; Email: gastro@catholic.ac.kr
    • Contact: Joon Sung Kim; Email: kijoons@catholic.ac.kr
    • Principal Investigator: Byung-Wook Kim, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination.

Participants who voluntarily want to participate in this study.

Exclusion Criteria:

History of H. pylori eradication History of stomach resection. Allergy or adverse events related to eradication medication. Administration of proton-pump inhibitor within 2 weeks or Histamine 2 receptor blocker within 1 week.

Administration of these drugs within a week or who need continuous administration of these drugs; aspirin (except low-dose aspirin for primary prophylaxis of cardiovascular disease), intravenous or oral NSAID, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate Administration of antibiotics within 4 weeks. Pregnant, breast feeding participant or who do not have a will to avoid pregnancy during clinical trial Administrating one of these drugs (Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergotamine, Dihydroergotamine, Mizolastine, Bepridil, Ticagrelor) Infectious mononucleosis Central nervous system infection Hematologic disease Galactose intolerance Lactase deficiency Glucose-galactose malabsorption Torsades de pointes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7-day triple therapy and 7-day bismuth quadruple therapy; 7-day triple therapy is consisted of proton pump inhibitor (PPI), amoxicillin and clarithromycin for seven days 7-day bismuth quadruple therapy is consisted of PPI, bismuth, tetracycline, metronidazole for seven days	Drug: Duration of eradication regimen; 14 day eradication regimen; Other Names: 14 day treatment
Active Comparator: 14-day triple therapy and 14-day bismuth quadruple therapy; 14-day triple therapy is consisted of PPI, amoxicillin and clarithromycin for fourteen days 14-day bismuth quadruple therapy is consisted of PPI, bismuth, tetracycline, metronidazole for fourteen days	Drug: Duration of eradication regimen; 14 day eradication regimen; Other Names: 14 day treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate	Negative urea breath test done	At least 4 weeks from eradication regimen

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Development of adverse events	Within one week from eradication administration

Collaborators and Investigators

• Sponsor: Incheon St.Mary's Hospital
• Collaborators: Korea Health Industry Development Institute
• Investigators: Principal Investigator: Byung-Wook Kim, MD, PhD, Incheon St.Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Helicobacter; Tailored; Empirical
• Other Study ID Numbers: Incheon HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No