Tailored Therapy for Clarithromycin-Resistant H. Pylori

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

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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