Menu
Recruiting NCT02373280

The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection

No phase Interventional Helicobacter Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole), 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy), 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin], 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy).
Who it may be relevant to
Registry conditions: Helicobacter Infection. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Single-center, Open-label, Clinical Trial to Compare the 10-day Sequential Therapy and 7-day Culture Based Tailored Therapy for the Eradication of Helicobacter Pylori

Overview

To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.

Detailed description

As increasing antimicrobial resistance in Korea, the effectiveness of empirical Helicobacter pylori (H. pylori) therapies have been declined. Recently, 10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication.

Thus, in this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days tailored therapy (7 day PPI based triple therapy, bismuth quadruple therapy or moxifloxacin contained triple therapy) for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 day sequential therapy for the first eradication of H. pylori infection, and the investigators analyzed the prevalence of the antibiotic resistance in the tailored therapy group.

Interventions

  • Drug 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)
    In this group, patients will receive the 10 day sequential regimen for eradication of H. pylori. 10 day sequential regimen is like follows; Esomeprazole 40 mg bid 10 days (D1-D10)+amoxicillin 1 g bid 5 days (D1-D5)+clarithromycin 500 mg bid 5 days (D6-D10)+metronidazole 500 mg tid 5 days (D6-D10).
  • Drug 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)
    the participants received PPI based triple therapy\[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\]
  • Drug 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]
    moxifloxacin triple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)\].
  • Drug 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)
    bismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+amoxicillin 1 g bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\], bismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, 300 mg qid 7 days (D1-D7)+Metronidazole, 500 mg tid 7 days (D1-D7)+Tetracycline 500 mg qid 7 days (D1-D7)\] If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was

Primary outcome measures

  • Compare the percentage of participants with successful H. pylori eradication in each groups [Time frame: 6 weeks after completion of eradication]

Eligibility criteria

Inclusion criteria

  • The patients who proved H. pylori infection following three methods
  • positive rapid urease test (CLOtest)
  • histologic evidence of H. pylori by modified Giemsa staining
  • positive Urea breath test
  • Male and female Korean Adult (Aged ≥ 18 years)

Exclusion criteria

  • Patients who received eradication therapy for H. pylori infection, previously
  • H. pylori eradication failure because of poor compliance
  • the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
  • Advanced gastric cancer or other malignancy
  • Abnormal liver function or liver cirrhosis
  • Abnormal renal function or chronic kidney disease
  • Other severe concurrent diseases
  • Previous allergic reactions to the study drugs
  • Pregnant or lactating women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Bundang Hospital — Seongnam-si

Identifiers

NCT: NCT02373280 · B-1407/259-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗