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Tailored H. Pylori Eradication Based on Clarithromycin Resistance

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ClinicalTrials.gov Identifier: NCT03884348
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Shin, Woon Geon, Kangdong Sacred Heart Hospital

Brief Summary:
The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.

Condition or disease Intervention/treatment
Helicobacter Pylori Infection Antibiotic Resistant Strain Drug: proton pump inhibitor, amoxicillin, clarithromycin Drug: proton pump inhibitor, amoxicillin, metronidazole

Detailed Description:

Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant.

Participants who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7 days. H. pylori eradication rates were compared between the two groups.


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Study Type : Observational
Actual Enrollment : 431 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PAM-treated clarithromycin-resistance group
Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and metronidazole (500 mg) three times a day for 7 days in patients with clinically significant point mutations
Drug: proton pump inhibitor, amoxicillin, metronidazole
clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole

PAC-treated nonresistance group
Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and clarithromycin (500 mg) twice a day for 7 day in patients with clinically insignificant point mutations
Drug: proton pump inhibitor, amoxicillin, clarithromycin
non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin




Primary Outcome Measures :
  1. Helicobacter pylori eradication rate [ Time Frame: 2 year ]
    Number of participant with successful Helicobacter pylori eradication



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Helicobacter-pylori positive patients with gastritis, ulcer, adenoma
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Helicobacter pylori infection

Exclusion Criteria:

  • H. pylori eradication therapy within 1 year,
  • antibiotics within 4 weeks,
  • surgery for gastric cancer
  • malignant tumors other than gastric cancer
  • end-stage renal disease
  • liver cirrhosis,
  • pregnancy

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): NCT03884348


Sponsors and Collaborators
Kangdong Sacred Heart Hospital
Investigators
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Principal Investigator: Woon Geon Shin Kangdong Sacred Heart Hospital

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Responsible Party: Shin, Woon Geon, Principal Investigator, Kangdong Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03884348     History of Changes
Other Study ID Numbers: Kangdong2017-03-005
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Clarithromycin
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Metronidazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors