VCM eradication therapy for penicillin allergy

JRCT ID: jRCTs031200171

Registered date:26/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 02/12/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Vonoprazan (20mg), clarithromycin (200mg), and metronidazole (250mg) given on twice daily for 7days

Outcome(s)

• Primary Outcome: Eradication rate
• Secondary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients infected with Helicobacter pylori. Patients allergic to penicillin. Patients who give a written informed consent.

Exclude criteria

Past history of Helicobacter pylori eradication therapy. Pregnancy or lactation. Past history of allergy for the drugs used in this therapy (vonoprazan, clarithromycin, or metronidazole).
Patients using atazanavir, rilpivirine, pimozide, ergotamine, suvorexant, lomitapide mesylate, tadalafil, ticagrelor, ibrutinib, asuna previr, ivavradine, venetoclax, lurasidone hydrochloride, anamorelin hydrochloride, finerenone, or isavuconazonium sulfate. Patients using colchicine with liver dysfunction or renal dysfunction. Patients with cerebrospinal disease. 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