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Tailored H. Pylori Eradication Based on Clarithromycin Resistance

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: 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

Tracking Information
First Submitted Date March 14, 2019
First Posted Date March 21, 2019
Last Update Posted Date March 21, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2019)
Helicobacter pylori eradication rate [ Time Frame: 2 year ]
Number of participant with successful Helicobacter pylori eradication
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tailored H. Pylori Eradication Based on Clarithromycin Resistance
Official Title Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance
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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Helicobacter-pylori positive patients with gastritis, ulcer, adenoma
Condition
  • Helicobacter Pylori Infection
  • Antibiotic Resistant Strain
Intervention
  • Drug: proton pump inhibitor, amoxicillin, clarithromycin
    non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin
  • Drug: proton pump inhibitor, amoxicillin, metronidazole
    clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole
Study Groups/Cohorts
  • 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
    Intervention: Drug: 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
    Intervention: Drug: proton pump inhibitor, amoxicillin, clarithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 20, 2019)
431
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03884348
Other Study ID Numbers Kangdong2017-03-005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Shin, Woon Geon, Kangdong Sacred Heart Hospital
Study Sponsor Kangdong Sacred Heart Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Woon Geon Shin Kangdong Sacred Heart Hospital
PRS Account Kangdong Sacred Heart Hospital
Verification Date March 2019