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

Single-arm prospectie interventional study of Helicobacter pylori eradication rescue therapy with rifabutin, sitafloxacin, and vonoprazan

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230735
Enrollment
40
Registered
2024-03-27
Start date
2024-04-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection Helicobacter pylori

Interventions

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 interven

Sponsors

Sue Soichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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, ensitrelvir, nirmatrelvir/ritonavir, avigan, rilpivirine, isavuconazonium, 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

Design outcomes

Primary

MeasureTime frame
Eradication rate

Secondary

MeasureTime frame
Treatment compliance, Safety

Contacts

Public ContactSoichiro Sue

Yokohama City University Hospital

ssue@yokohama-cu.ac.jp+81-457872326

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026