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

JRCT ID: jRCTs031180362

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 25/03/2016
• Target sample size: 100
• Study type: Interventional
• Intervention(s): vonoprazan 40mg, b.i.d., amoxicillin 2.0g, q.i.d., rifabutin 300mg, o.d. 7 days

Outcome(s)

• Primary Outcome: The efficacy of eradication treatment

Secondary Outcome

1) MIC of AMPC and RFB
2) rpoB mutation analysis of H.pylori

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: H. pylori-positve patients after the 2nd line H. pylori eradication therapy with informed consent

Exclude 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

Related Information

• Primary Sponsor: Hirata Kenro