15-day Sequential Therapy for Helicobacter Pylori Infection in Korea

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: metronidazole; Drug: Clarithromycin; Drug: esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01887249

B-1007/106-001

Details and patient eligibility

About

10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication in Korea due to high antimicrobial resistance. The present investigators assumed that doubling duration of second phase of sequential therapy might have more potent bactericidal efficacy than previous 10-day sequential regimen. But 15-day regimen with initial 5-day PPI with amoxicillin followed by remaining 10-day PPI, clarithromycin with metronidazole was not ever tested before. Moreover, whether extending the sequential therapy to 15-day might be more effective than 10-day sequential therapy is unknown especially in Korea. From this background, the present investigators prepared clinical trials regarding modified sequential therapy which was extending the treatment duration to 15 days compared than previous 10-day sequential therapy regimen. In addition, pre-treatment antimicrobial susceptibility testing was performed to find the possibility to overcome antimicrobial resistance.

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with H. pylori infection who had never received treatment for H. pylori infection
• H. pylori infection defined by a positive rapid urease test (CLOtest, Delta West, Bentley, Australia) by gastric mucosal biopsy from the lesser curvature of the mid antrum or mid body or histological evidence of H. pylori by modified Giemsa staining in the lesser and greater curvature of the mid antrum or mid body, respectively or a positive C-urea breath test.

Exclusion criteria

• Patients with concurrent critical illness, a history of previous upper gastrointestinal surgery, contraindication to any of the study medications, recent frequent intake of NSAIDs, anticoagulants or steroids, an allergy to the study medications, and those that were pregnant or breast-feeding women were excluded from the study. Other exclusion criteria include recent use of antimicrobials and any condition probably associated with poor compliance such as drug abusers or alcoholics.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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287 participants in 3 patient groups

15 day sequential eradication therapy

Experimental group

Description:

the 15-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for 10 days.

Treatment:

Drug: esomeprazole

Drug: Clarithromycin

Drug: metronidazole

10-day sequential eradication therapy

Active Comparator group

Description:

the 10-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five days

Treatment:

Drug: esomeprazole

Drug: Clarithromycin

Drug: metronidazole

7-day PPI triple eradication therapy

No Intervention group

Description:

7-day PPI triple therapy regimen, which consisted of esomeprazole (40mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days.