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Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori

Comparison Between Ten Days Sequential Treatment (With Metronidazole or Tetracycline) and Ten Days Standard Triple Therapy of Helicobacter Pylori

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01573975
Enrollment
345
Registered
2012-04-10
Start date
2009-01-31
Completion date
2011-05-31
Last updated
2012-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori, antibiotic resistance, sequential therapy, Taiwan

Brief summary

The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.

Detailed description

Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide. Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese people. Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers and infected by H. pylori. Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host. Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.) for 10 days.

Interventions

DRUG5RA-5RCM

rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + metronidazole 500mg b.i.d x last 5 days.

DRUG5RA-5RCT

rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + tetracycline 1000mg b.i.d x last 5 days.

DRUG10RCA

rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d x 10 days.

Sponsors

Buddhist Tzu Chi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* patient proved with infection of H. pylori in gastric mucosa * adult with signed inform consent

Exclusion criteria

* woman in breast feeding or pregnancy. * allergy to drugs used in study. * three months without use of any antibiotic agents. * patients under 20 years old.

Design outcomes

Primary

MeasureTime frameDescription
Eradication rate4 weeks after complete use of drug for treatmentA negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026