Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Empirical vs Tailored Therapy for H. Pylori Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04006340
Recruitment Status : Enrolling by invitation
First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Soo-Jeong Cho, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation Helicobacter Pylori Infection Combination Product: triple therapy Combination Product: quadruple therapy Diagnostic Test: dual-priming oligonucleotide-based multiplex (DPO)-PCR test Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Empirical and Genotypic Resistance Guided Tailored Therapy for Helicobacter Pylori Infection
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Empirical group
Patients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days
Combination Product: triple therapy
esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days

Active Comparator: Genotypic resistance-guided tailored group

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.

Combination Product: triple therapy
esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days

Combination Product: quadruple therapy
esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days

Diagnostic Test: dual-priming oligonucleotide-based multiplex (DPO)-PCR test
Resistance of clarithromycin 23S rRNA point mutation




Primary Outcome Measures :
  1. Eradication rate [ Time Frame: 13C-UBT at least 4 weeks after completion of treatment ]
    Eradication rate of H. pylori infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04006340


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Soo-Jeong Cho, M.D., ph.D. Department of Internal Medicine and Liver Research Institute,
Layout table for additonal information
Responsible Party: Soo-Jeong Cho, Clinical Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04006340    
Other Study ID Numbers: 1811-029-983
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections