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

NCT04147065 | Recruiting Phase 4

• 1 other identifier: Incheon HP
• Study Type: interventional
• Target: 1,230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter; Empirical; Tailored

Outcome Measures

Primary Outcomes (1)

• Eradication rate

  Negative urea breath test done

  At least 4 weeks from eradication regimen

Secondary Outcomes (1)

• Adverse events

  Within one week from eradication administration

Study Arms (2)

7-day triple therapy and 7-day bismuth quadruple therapy

EXPERIMENTAL

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 triple therapy and 14-day bismuth quadruple therapy

ACTIVE COMPARATOR

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

Interventions

Duration of eradication regimen DRUG

14 day eradication regimen

Also known as: 14 day treatment

14-day triple therapy and 14-day bismuth quadruple therapy; 7-day triple therapy and 7-day bismuth quadruple therapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incheon St.Mary's Hospital: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

Incheon St. Mary's Hospital

Incheon, South Korea

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Byung-Wook Kim, MD, PhD

  Incheon St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon S Kim, MD, PhD

CONTACT

82322805057; kijoons@nate.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Phase I study Tailored therapy (Clar S: 7 vs. 14 d triple therapy, Clar R: 7 vs. 14d BQT) vs. empirical therapy (7 or 14 d triple therapy) for H. pylori eradication Phase 2 study Tailored therapy (Clar S: 7d triple therapy, Clar R: 7d BQT vs. empirical therapy (14d triple therapy)

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 31, 2019
• Study Start: July 14, 2021
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)