Tailored Therapy for Clarithromycin-Resistant H. Pylori

K

Kangdong Sacred Heart Hospital

Status

Unknown

Conditions

Helicobacter Pylori Infection

Treatments

Drug: PAM
Drug: PBMT

Study type

Interventional

Funder types

Other

Identifiers

NCT03431688
KangdongSHH

Details and patient eligibility

About

Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.

Enrollment

660 estimated patients

Sex

All

Ages

19 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • peptic ulcer disease
  • H. pylori gastritis
  • low grade MALT lymphoma

Exclusion criteria

  • history of gastric cancer surgery
  • severe comorbidity (ESRD, LC)
  • hypersensitivity to drug
  • pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

660 participants in 2 patient groups

PAM
Active Comparator group
Description:
treatment with PPI, metonidazole, amoxicillin
Treatment:
Drug: PAM
PBMT
Active Comparator group
Description:
treatment with PPI, metonidazole, bismuth, tetracyclin
Treatment:
Drug: PBMT

Trial contacts and locations

1

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Central trial contact

Woon Geon Shin

Data sourced from clinicaltrials.gov

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