NCT04147065

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,230 (estimated)
• Sponsor: Incheon St.Mary's Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Duration of eradication regimen	14 day eradication regimen

Timeline

• Start date: 2021-07-14
• Primary completion: 2024-12-31
• Completion: 2025-03-30
• First posted: 2019-10-31
• Last updated: 2024-05-16

Locations

1 site across 1 country: South Korea