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Empirical vs Tailored Therapy for H. Pylori Infection

Primary Purpose

Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation, Helicobacter Pylori Infection

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
triple therapy
quadruple therapy
dual-priming oligonucleotide-based multiplex (DPO)-PCR test
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with H. pylori who had undergone endoscopic resection for gastric neoplasm
  • Patients with H. pylori who had diagnosed at peptic ulcer disease, MALT lymphoma

Exclusion Criteria:

  • history of gastrectomy
  • patients aged younger than 20 years or older than 80 years
  • history of H. pylori eradication therapies or other antibiotics therapy within a month
  • previous allergic reaction to the study drugs (amoxicillin, clarithromycin, metronidazole, tetracycline, and esomeprazole)
  • contraindication to treatment drugs
  • pregnant or lactating women
  • severe concurrent illness

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Empirical group

Genotypic resistance-guided tailored group

Arm Description

Patients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days

Patients receive triple or quadruple therapy by resistance-associated mutations in 23S ribosomal RNA which are identified by polymerase chain reaction (PCR). Triple therapy contains esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days and quadruple therapy contains esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days.

Outcomes

Primary Outcome Measures

Eradication rate
Eradication rate of H. pylori infection

Secondary Outcome Measures

Full Information

First Posted
June 28, 2019
Last Updated
July 1, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04006340
Brief Title
Empirical vs Tailored Therapy for H. Pylori Infection
Official Title
Comparison of Empirical and Genotypic Resistance Guided Tailored Therapy for Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials.
Detailed Description
Empirical therapy is conventional triple therapy (proton pump inhibitor (PPI) standard dose, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days). Genotypic resistance-guided tailored therapy is the method which is chosen by DPO-PCR test. While the patients who have positive result of clarithromycin resistance receive the quadruple therapy(PPI standard dose, bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days), clarithromycin susceptible patients receive the triple therapy. H. pylori is difficult to cultivate, cultivation of H. pylori and minimum inhibitory concentration test as a resistance test method are very difficult and take a long time. Recently, tailored treatment based on clarithromycin susceptibility has been proposed by dual-priming oligonucleotide-based multiplex (DPO)-PCR test. This is a method to confirm the mutation of A2142G and A2143G by PCR, which are known to be highly related to the resistance of clarithromycin 23S rRNA point mutation. This test is performed only by gastric biopsy. The examination time is also short as several hours, and sensitivity and specificity are about 80-85%. Antibiotic resistance of H. pylori, especially clarithromycin resistance, is a cause of major failure of its eradication, and Korea 's clarithromycin resistance rate is reported to be about 37%. The eradication rate of standard triple therapy reported in Korea is also unsatisfactory as antibiotic resistance rate of H. pylori increases. The ideal eradication rate for H. pylori is approximately 90%, but in the meta-analysis of the recently reported primary eradication, the overall eradication rate was 74.6% in the intention to treat analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation, Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empirical group
Arm Type
Placebo Comparator
Arm Description
Patients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days
Arm Title
Genotypic resistance-guided tailored group
Arm Type
Active Comparator
Arm Description
Patients receive triple or quadruple therapy by resistance-associated mutations in 23S ribosomal RNA which are identified by polymerase chain reaction (PCR). Triple therapy contains esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days and quadruple therapy contains esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days.
Intervention Type
Combination Product
Intervention Name(s)
triple therapy
Intervention Description
esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days
Intervention Type
Combination Product
Intervention Name(s)
quadruple therapy
Intervention Description
esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days
Intervention Type
Diagnostic Test
Intervention Name(s)
dual-priming oligonucleotide-based multiplex (DPO)-PCR test
Intervention Description
Resistance of clarithromycin 23S rRNA point mutation
Primary Outcome Measure Information:
Title
Eradication rate
Description
Eradication rate of H. pylori infection
Time Frame
13C-UBT at least 4 weeks after completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with H. pylori who had undergone endoscopic resection for gastric neoplasm Patients with H. pylori who had diagnosed at peptic ulcer disease, MALT lymphoma Exclusion Criteria: history of gastrectomy patients aged younger than 20 years or older than 80 years history of H. pylori eradication therapies or other antibiotics therapy within a month previous allergic reaction to the study drugs (amoxicillin, clarithromycin, metronidazole, tetracycline, and esomeprazole) contraindication to treatment drugs pregnant or lactating women severe concurrent illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-Jeong Cho, M.D., ph.D.
Organizational Affiliation
Department of Internal Medicine and Liver Research Institute,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33094958
Citation
Kim JL, Cho SJ, Chung SJ, Lee A, Choi J, Chung H, Kim SG. Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2020 Sep;11(9):e00194. doi: 10.14309/ctg.0000000000000194.
Results Reference
derived

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Empirical vs Tailored Therapy for H. Pylori Infection

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