Comparison of Two Rescue Therapies for Helicobacter Pylori Infection

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: esomeprazole+amox+levo+tetra; Drug: esomeprazole+amox+levo

• Registration Number: NCT02547012
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Detailed Description

The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either EALT (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.) therapy or EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2015-09-06
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Primary Completion: 2017-07
• Study Completion: 2017-10
• Results First Submitted: 2017-10-20
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Results First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• positive results of both rapid urease test and histology,
• a positive result of urea breath test,
• or a positive result of culture.

Exclusion Criteria

• ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
• patients with allergic history to the medications used,
• patients with previous gastric surgery,
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esomeprazole+amox+levo+tetra	esomeprazole+amox+levo+tetra	esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
esomeprazole+amox+levo	esomeprazole+amox+levo	esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.

Primary Outcome Measures

Name	Time	Method
Number of Participants in Which H. Pylori Was Eradicated	six weeks after the end of anti-H pylori therapy.	Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan