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

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ClinicalTrials.gov Identifier: NCT02373280
Recruitment Status : Recruiting
First Posted : February 27, 2015
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Helicobacter Infection Drug: 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole) Drug: 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy) Drug: 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin] Drug: 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients selected study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Active Comparator: 10 day sequential group
After proving H. pylori infection, the participant will receive the empirical 10 day sequential regimen (Esomeprazole, nexium® 40 mg bid 10 days (D1-D10)+amoxicillin® 1 g bid 5 days (D1-D5)+clarithromycin, klaricid® 500mg bid 5 days (D6-D10)+metronidazole, flasinyl® 500mg tid 5 days (D6-D10) for treatment of H. pylori infection in this group.
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).

Experimental: 7 days tailored PPI triple therapy group
After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day tailored regimen [PPI triple therapy (Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+amoxicillin® 1 g bid 7 days (D1-D7)+clarithromycin, klaricid® 500mg bid 7 days (D1-D7)] in this group.
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)]
Other Name: 7d PPI triple therapy

Experimental: 7 days tailored MEA therapy group
After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day moxifloxacin triple therapy [Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+Moxifloxacin, avelox® 400 mg qd 7 days (D1-D7)+Amoxicillin® 1 g bid 7 days (D1-D7)] in this group.
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)].
Other Name: 7d MEA triple therapy

Experimental: 7 or 14 days tailored EBMT therapy group
After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day bismuth quadruple therapy [Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, denol® 300 mg qid 7 days (D1-D7)+Metronidazole, flasinyl® 500 mg tid 7 days (D1-D7)+Tetracycline® 500 mg qid 7 days (D1-D7)] in this group. If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days.
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 14 days.
Other Name: 7d or 14d quadruple therapy




Primary Outcome Measures :
  1. Compare the percentage of participants with successful H. pylori eradication in each groups [ Time Frame: 6 weeks after completion of eradication ]
    The efficacy of H. pylori eradication between a 7 days tailored therapy for H. pylori infection based on the results of antimicrobial resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 days therapy as first eradication regimen.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The patients who proved H. pylori infection following three methods

    1. positive rapid urease test (CLOtest)
    2. histologic evidence of H. pylori by modified Giemsa staining
    3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373280


Contacts
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Contact: Nayoung Kim, M.D., Ph. D 82-31-787-7008 nayoungkim49@empas.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Nayoung Kim, M.D, Ph.D    +82-31-787-7008    nayoungkim49@empas.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Nayoung Kim, M.D., Ph. D Seoul National University Bundang Hospital

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Responsible Party: Nayoung Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02373280     History of Changes
Other Study ID Numbers: B-1407/259-005
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019

Keywords provided by Nayoung Kim, Seoul National University Bundang Hospital:
Helicobacter pylori
tailored therapy
eradication

Additional relevant MeSH terms:
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Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Moxifloxacin
Metronidazole
Clarithromycin
Esomeprazole
Bismuth
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
Proton Pump Inhibitors
Protein Synthesis Inhibitors