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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04147065
• Other study ID #: Incheon HP
• Status: Recruiting
• Phase: Phase 4
• Start date: July 14, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2024
• Source: Incheon St.Mary's Hospital
• Contact: Joon S Kim, MD, PhD
• Phone: 82322805057
• Email: kijoons[@]nate.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1230
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Duration of eradication regimen
14 day eradication regimen

Locations

Country	Name	City	State
Korea, Republic of	Incheon St. Mary's Hospital	Incheon

Sponsors (2)

Lead Sponsor	Collaborator
Incheon St.Mary's Hospital	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate	Negative urea breath test done	At least 4 weeks from eradication regimen
Secondary	Adverse events	Development of adverse events	Within one week from eradication administration