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The Efficacy of the 7 Days Tailored Therapy as 2nd Rescue Therapy for Eradication of H. Pylori Infection

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ClinicalTrials.gov Identifier: NCT02359331
Recruitment Status : Recruiting
First Posted : February 10, 2015
Last Update Posted : April 19, 2019
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 coincidentally.

In this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days 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 14 days bismuth contained quadruple 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 testing Drug: 14 days empirical bismuth quadruple therapy (Proton pump inhibitor) Drug: Metronidazole Drug: Tetracycline Drug: tripotassium dicitrate bismuthate Drug: 7 days tailored therapy Proton Pump Inhibitor Drug: Moxifloxacin Drug: Amoxicillin 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 14 days bismuth quadruple 2nd rescue therapy and the 7 days tailored therapy for H. pylori infection based on culture and MIC, the patients were randomly classified into the two 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.), or 7 days tailored therapy based on H. pylori culture and MIC (select the 2nd rescue regimen between 7 days of bismuth-based quadruple therapy or 7 days moxifloxacin-containing triple therapy (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.) according to antibiotics susceptibility.

This study was designed to evaluate the success of eradication for enrolled participants by methods of an open labelled randomized prospectively.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare the 14-day Bismuth Quadruple Therapy and 7-day Culture Based Tailored Therapy for the Eradication of Helicobacter as a Rescue 2nd Therapy.
Study Start Date : August 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Active Comparator: 14 days PBMT group
Giving the 14 days bismuth quadruple regimen as 2nd rescue therapy for eradication of persistent H. pylori infection Drug 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
Drug: 14 days empirical bismuth quadruple therapy (Proton pump inhibitor)

Giving the 14 days PBMT regimen as 2nd rescue 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.


Drug: Metronidazole
Drug: Tetracycline
Drug: tripotassium dicitrate bismuthate
Experimental: 7 days tailored therapy group
According the antimicrobial susceptibility testing, the H. pylori isolates were resistant to moxifloxacin, 7 days PBMT regimen were prescribed; if the isolates were resistant to metronidazole, 7 days moxiflxacin based triple regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d) were prescribed.
Procedure: H. pylori culture and antimicrobial susceptibility testing

This intervention will be performed in 7 days tailored therapy group.

All the patients who enrolled in this arm, they will be received endoscopy guided biopsy procedure. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin, clarithromycin, metronidazo, tetracycline and moxifloxacin for the H. pylori isolates were examined by use of the serial two fold agar dilution method


Drug: 7 days tailored therapy Proton Pump Inhibitor
Drug: Moxifloxacin
Drug: Amoxicillin



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 14 days bismuth quadruple therapy as 2nd rescue regimens.

    The eradication rate was evaluated by intention to treat (ITT) and per-protocol (PP) analysis




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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 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): NCT02359331


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
Principal Investigator: Nayoung Kim, M.D.,Ph.D.         
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: NCT02359331     History of Changes
Other Study ID Numbers: B1408/285-005
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

Keywords provided by Nayoung Kim, Seoul National University Bundang Hospital:
Helicobacter pylori
resistance
rescue therapy

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