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

Single-arm prospective interventional study of Helicobacter pylori eradication rescue therapy with rifabutin, metronidazole, and vonoprazan

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031220504
Enrollment
20
Registered
2022-12-09
Start date
2023-01-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection Helicobacter pylori

Interventions

Rifabutin 150mg bid (300mg/day), metronidazole 250mg bid (500mg/day), and vonoprazan 20mg bid (40mg/day) 10days

Sponsors

Sue Soichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Eradication rate

Secondary

MeasureTime frame
Safety

Contacts

Public ContactSoichiro Sue

Yokohama City University Hospital

ssue@yokohama-cu.ac.jp+81-457872800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026