H. pylori rescue eradication therapy with rifabutin, metronidazole, and vonoprazan

JRCT ID: jRCTs031220504

Registered date:09/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 18/01/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Rifabutin 150mg bid (300mg/day), metronidazole 250mg bid (500mg/day), and vonoprazan 20mg bid (40mg/day) 10days

Outcome(s)

• Primary Outcome: Eradication rate
• Secondary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who was diagnosed as Helicobacter pylori infection. Helicobacter pylori infection was defined urea breath test positive, Helicobacter pylori stool antigen test positive, Helicobacter pylori culture positive, or rapid urease test positive in this study.
(2) Patients with history of first line national insurance covered eradication (vonoprazan or PPI + amoxicillin + clarithromycin 7days triple therapy) failure and second line national insurance covered eradication (vonoprazan or PPI + amoxicillin + metronidazole 7dasy triple therapy) failure (third line or later), or patients with penicillin allergy who cannot eradicate with amoxicillin containing national insurance covered first and second line eradication regimens.
(3) Patients who give a written informed consent.

Exclude criteria

(1) Past history of allergy for rifabutin and rifampicin
(2) Patients using voriconazole, grazoprevir, elbasvir, ticagrelor, artemether, lumefantrine, rilpivirine emtricitabine tenofovir alafenamide, atazanavir sulfate, and rilpivirine hydrochloride
(3) Patients with history of allergy for metronidazole
(4) Patients with brain and spinal cord disease
(5) Pregnancy or lactation
(6) Patients who was diagnosed as vonoprazan allergy at present time
(7) Severe liver dysfunction. Severe renal dysfunction
(8) Patients who are disqualified for the study by physicians

Related Information

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