The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regime

Not Applicable

• Conditions: Helicobacter pylori infection; A498

• Registration Number: JPRN-jRCTs031180362
• Lead Sponsor: Hirata Kenro

Brief Summary

Seven-day low-dose RFB-based VAR therapy is effective and safe as a third- or later-line H. pylori eradication regimen.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study Completion: 2021-05-07
• Results First Posted: 2021-05-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

H. pylori-positve patients after the 2nd line H. pylori eradication therapy with informed consent

Exclusion Criteria

1. Patients with allergy for rifamycins
2. Patients with past histry of tuberculosis or nontuberculous mycobacterial infection
3. Patients with allergy for PPIs
4. Patients with allergy for penicillin
5. Patients with severe liver injury and/or severe renal damage
6. Pregnancy or possible pregnancy
7. Patients who are taking voriconazole
8. Patients with uveitis
9. Patients who were recognized as inappropriate for entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of eradication treatment

Secondary Outcome Measures

Name	Time	Method
1) MIC of AMPC and RFB <br>2) rpoB mutation analysis of H.pylori