PCAB-based H.pylori eradication study for patients with penicillin allergy (CAP-pen study)

JRCT ID: jRCTs031180133

Registered date:19/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 09/03/2015
• Target sample size: 60
• Study type: Interventional

Intervention(s)

First line eradication:
clarithromycin(CAM)+metronidazole(MNZ)+Vonoprazan 7days
Second line eradication:
metronidazole(MNZ)+sitafloxacin(STFX)+Vonoprazan 7days

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: Penicillin allergic patients with H.pylori infection who want to take eradication treatment. Patients who give a written informed consent.
• Exclude criteria: Past history of taking second line H.pylori eradication therapy. Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. 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): UMIN000016335