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Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection

K

Kaohsiung Veterans General Hospital

Status

Completed

Conditions

Helicobacter Pylori Infection

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02978157
VGHKS104-062

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 EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) or EBTL (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) therapy 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

102 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)

102 participants in 2 patient groups

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
esomeprazole+bismuth+tetra+levo
Experimental group
Description:
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
Treatment:
Drug: esomeprazole+bismuth+tetra+levo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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