H. pylori rescue eradication therapy with lascufloxacin, amoxicillin, and vonoprazan

JRCT ID: jRCTs031200154

Registered date:15/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 18/11/2020
• Target sample size: 23
• Study type: Interventional
• Intervention(s): Vonoprazan 20mg bid (40mg/day), amoxicillin 750mg bid (1500mg/day), and lascufloxacin 75mg sid (75mg/day) 7days

Outcome(s)

• Primary Outcome: Eradication rate (FAS)

Secondary Outcome

(1) Eradication rate (PPS)
(2) Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Patients diagnosed with Helicobacter pylori infection
(2)Patients with clarithromycin and metronidazole resistant H. pylori infection or patients who failed eradication by both triple therapy with clarithromycin and amoxicillin and triple therapy with metronidazole and amoxicillin.

Exclude criteria

(1)Past history of allergy for vonoprazan, amoxicillin, or lascufloxacin.
(2)Patients with infectious mononucleosis.
(3)Patients taking atazanavir or rilpivirine.
(4)Pregnancy.
(5)Lactation.
(6)Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction.
(7)Patients who are disqualified for the study by physicians.

Related Information

• Primary Sponsor: Sue Soichiro
• Source(s) of Monetary Support: Yokohama City University