Clinical trial NCT04147065: Helicobacter Pylori Eradication According to DPO-PCR Methods (K-CREATE) Study)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter
Empirical
Tailored
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2019-10-31
Enrollment: 1230
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eradication rate
timeFrame: At least 4 weeks from eradication regimen
Secondary outcomes:
measure: Adverse events
timeFrame: Within one week from eradication administration
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
Study officials:
affiliation: Incheon St.Mary's Hospital
name: Byung-Wook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: