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

Phase 2

• Conditions: Helicobacter pylori infection; Helicobacter pylori

• Registration Number: JPRN-jRCTs031220504
• Lead Sponsor: Sue Soichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified