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Trial record 21 of 603 for:    Anti-Infective Agents AND susceptibility

The Efficacy of the Tailored Therapy Based on Antimicrobial Susceptibility for 2nd Eradication of H. Pylori

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ClinicalTrials.gov Identifier: NCT02349685
Recruitment Status : Completed
First Posted : January 29, 2015
Results First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital

Brief Summary:
As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidently. In this study, the investigators evaluated the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.

Condition or disease Intervention/treatment Phase
Helicobacter Infection Procedure: H. pylori culture and antimicrobial susceptibility test Drug: 14 day PBMT group Drug: 14 day MEA group Not Applicable

Detailed Description:
The patients who had shown the evidence of persistent H. pylori infection after the 1st eradication were enrolled for this study. After giving the informed consent about the method and efficacy (ITT and PP analysis) of the traditional 2nd rescue therapy and the tailored therapy for H. pylori infection based on culture and MIC, the patients were classified into the three regimen group under the patient's agreement and underwent 2nd eradication [14 days bismuth-based quadruple therapy (Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.), 14 days moxifloxacin-containing triple therapy (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.), or tailored therapy based on H. pylori culture and MIC (select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility)].This study was analyzed the success of eradication for enrolled participants retrospectively, however the patients were enrolled prospectively based on previous study about antimicrobial susceptibility test for H. pylori in Korea.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of the Culture Based Tailored Therapy for Helicobacter Pylori Eradication Comparing With the Traditional 2nd Line Rescue Therapy in Korean
Study Start Date : January 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: 14 day bismuth based quadruple therapy (PBMT) group
Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
Drug: 14 day PBMT group
Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]

Experimental: 14 day Moxifloxacin containing triple therapy (MEA) group
PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
Drug: 14 day MEA group
Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)

Active Comparator: 14 day tailored therapy group
based on H. pylori culture and antimicrobial sensitivity, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
Procedure: H. pylori culture and antimicrobial susceptibility test
Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute [amoxicillin (AMC), MIC ≥ 0.5 μg / ml; clarithromycin (CLA), MIC > 1.0 μ g / ml; metronidazole (MET), MIC > 8 μ g / ml; tetracycline (TC), MIC > 4 μ g / ml; and moxifloxacin (MOX), MIC > 1 μ g / ml).




Primary Outcome Measures :
  1. Number of Participants in Each Arm/Group With Successful H. Pylori Eradication [ Time Frame: 6 weeks after completion of eradication ]

    the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.

    The eradication rate was evaluated by intention to treat (ITT)



Secondary Outcome Measures :
  1. Number of Participants in Each Arm/Group With Successful H. Pylori Eradication [ Time Frame: 6 weeks after completion of eradication ]

    the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.

    The eradication rate was evaluated by per-protocol analysis (PP)




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The patients who proved a failure of 1st eradication of H. pylori with Proton pump inhibitor based triple therapy (PPI bid + amoxacillin 1g b.i.d + Clarithromycin 500 mg b.i.d) or sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d) following three methods

    1. positive rapid urease test (CLOtest)
    2. histologic evidence of H. pylori by modified Giemsa staining
    3. positive 13C-Urea breath test
  • Male and female Korean Adult (Aged ≥ 18 years)

Exclusion Criteria:

  • Patients who received two or more eradication therapy for H. pylori infection
  • 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): NCT02349685


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nayoung Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02349685     History of Changes
Other Study ID Numbers: B-1412/280-119
First Posted: January 29, 2015    Key Record Dates
Results First Posted: October 4, 2016
Last Update Posted: October 4, 2016
Last Verified: August 2016
Keywords provided by Nayoung Kim, Seoul National University Bundang Hospital:
Helicobacter pylori
Personalized therapy
antimicrobial susceptibility
rescue therapy
culture
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Moxifloxacin
Metronidazole
Tetracycline
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
Protein Synthesis Inhibitors