Tailored H. Pylori Eradication Based on Clarithromycin Resistance

NCT03884348 | Completed

• 1 other identifier: Kangdong2017-03-005
• Study Type: observational
• Target: 431
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Infection; Antibiotic Resistant Strain

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Number of participant with successful Helicobacter pylori eradication

  2 year

Study Arms (2)

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

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

Interventions

proton pump inhibitor, amoxicillin, clarithromycin DRUG

non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin

PAC-treated nonresistance group

proton pump inhibitor, amoxicillin, metronidazole DRUG

clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole

PAM-treated clarithromycin-resistance group

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Helicobacter-pylori positive patients with gastritis, ulcer, adenoma

You may qualify if:

• Clinical diagnosis of Helicobacter pylori infection

You may not qualify if:

• 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

Sponsors & Collaborators

• Kangdong Sacred Heart Hospital: lead

MeSH Terms

Interventions

Proton Pump Inhibitors; Amoxicillin; Clarithromycin; Metronidazole

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Woon Geon Shin

  Kangdong Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 21, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share