H. pylori rescue eradication therapy with rifabutin, sitafloxacin, and vonoprazan

JRCT ID: jRCTs031230735

Registered date:27/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 10/04/2024
• Target sample size: 40
• Study type: Interventional

Intervention(s)

If a positive Helicobacter pylori culture test is confirmed after study registration, the following therapeutic interventions will be performed. If the test result is negative, no therapeutic intervention will be performed and the study will end.
Rifabutin 150mg bid (300mg/day), sitafloxacin100mg bid (200mg/day), and vonoprazan 20mg bid (40mg/day) 10days

Outcome(s)

• Primary Outcome: Eradication rate
• Secondary Outcome: Treatment compliance, Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients diagnosed with Helicobacter pylori infection.
(2) Failed national insurance covered first-line eradication treatment (7-day treatment with 3 drugs of vonoprazan or PPI, amoxicillin, and clarithromycin) and national insurance covered second-line eradication treatment (7-day treatment with 3 drugs of vonoprazan or PPI, amoxicillin, and metronidazole), or , People who are unable to receive national insurance covered first-line, second-line eradication treatment due to penicillin allergy.
(3) Patients who can provide written consent to participate in this study

Exclude criteria

(1) Patients with a history of hypersensitivity to rifabutin or rifampicin
(2) Patients receiving the following drugs: voriconazole, grazoprevir, elbasvir, ticagrelor, artemether/lumefantrine, rilpivirine/tenofovir, alafenamide/emtricitavir, atazanavir sulfate, rilpivirine hydrochloride
(3) Patients with hypersensitivity to sitafloxacin or other quinolone antibiotics
(4) Those who are pregnant or may be pregnant
(5) Patients currently diagnosed with drug allergy due to vonoprazan
(6) Patients with other serious diseases (liver failure, renal failure, etc.).
(The standard for liver function is total bilirubin 1.5 mg/dL or less, and the standard for renal function is creatinine 1.2 mg/dL or less.)
(7) Other patients who are judged to be inappropriate by the doctor's judgment

Related Information

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