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Comparison of Two Rescue Therapies for Helicobacter Pylori Infection

K

Kaohsiung Veterans General Hospital

Status

Completed

Conditions

Helicobacter Pylori Infection

Treatments

Drug: esomeprazole+amox+levo
Drug: esomeprazole+amox+levo+tetra

Study type

Interventional

Funder types

Other

Identifiers

NCT02547012
VGHKS13-CT11-15

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

51 participants in 2 patient groups

esomeprazole+amox+levo+tetra
Experimental group
Description:
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
Treatment:
Drug: esomeprazole+amox+levo+tetra
esomeprazole+amox+levo
Active Comparator group
Description:
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
Treatment:
Drug: esomeprazole+amox+levo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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