Tailored H. Pylori Eradication Based on Clarithromycin Resistance

Kangdong Sacred Heart Hospital

Status: Completed

Conditions: Helicobacter Pylori Infection; Antibiotic Resistant Strain

Treatments: Drug: proton pump inhibitor, amoxicillin, metronidazole; Drug: proton pump inhibitor, amoxicillin, clarithromycin

Study type: Observational

Funder types: Other

Identifiers

NCT03884348

Kangdong2017-03-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 431 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

431 participants in 2 patient groups

PAM-treated clarithromycin-resistance group

Description:

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

Treatment:

Drug: proton pump inhibitor, amoxicillin, metronidazole

PAC-treated nonresistance group

Description:

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

Treatment:

Drug: proton pump inhibitor, amoxicillin, clarithromycin