Susceptibility based Fourth-line eradication

JRCT ID: jRCTs031180208

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 14/07/2017
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Vonoprazan 20mg bid
Amoxicillin 500mg qid
Clarithromycin 400mg bid
Metronidazole 250mg bid
2 weeks
This regimen is used with modification based on susceptibility testing of Helicobacter pylori about amoxicillin, clarithromycin and metronidazole.

1)All susceptible case: no modification.
2)One of amoxicillin, clarithromycin or metronidazole is resistant: the resistant drug is removed from the regimen
3)Two of amoxicillin, clarithromycin or metronidazole are resistant: the resistant drugs are removed from the regimen.
No susceptibility testing results: no modification.

Outcome(s)

• Primary Outcome: Eradication rate
• Secondary Outcome: Adverse event by questionnaire

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

A patient with Helicobacter pylori infection failed for first, second (one week triple therapy with acid suppressant and amoxicillin and clarithromycin or metronidazole) and sitafloxacin based third line eradication .
A patient who was diagnosed for Helicobacter pylori infection by urea breath test or Helicobacter pylori stool antigen test.
A patient who can perform urea breath test after 8 weeks from treatment completion.
A patient who give a written informed consent.

Exclude criteria

A patient who don't agree for endoscopy and susceptible testing as own expense medical care before eradication therapy.
Past history of allergy or side effect requiring treatment for the drugs used in this study.
Pregnancy or lactation. A patient with brain and spinal cord disease. A patient with infectious mononucleosis. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patients who are disqualified for the study by physicians.

Related Information

• Primary Sponsor: Sue Soichiro
• Source(s) of Monetary Support: Yokohama City University
• Secondary ID(s): UMIN000025765