Third line H. pylori eradication therapy with sitafloxacin, amoxicillin and vonaprazan

JRCT ID: jRCTs031180413

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 09/05/2016
• Target sample size: 100
• Study type: Interventional
• Intervention(s): vonaprazan 40mg, b.i.d., amoxicillin 2.0g, q.i.d., sitafloxacin 200 mg, b.i.d.

Outcome(s)

• Primary Outcome: The efficacy of eradication treatment

Secondary Outcome

1) adverse events
2) MIC of STFX,AMPC, gyaA mutation

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 quinolones
2. Patients with allergy for PPIs
3. Patients with severe liver injury and/or severe renal damage
4. Pregnancy or possible pregnancy
5. Patients who were recognized as inappropriate for entry

Related Information

• Primary Sponsor: Hirata Kenro
• Secondary ID(s): UMIN000022236