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Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

Effectiveness of Rifabutin Triple Therapy for First-line and Rescue Treatment of Helicobacter Pylori Infection

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04652284
Enrollment
300
Registered
2020-12-03
Start date
2021-05-01
Completion date
2023-07-31
Last updated
2021-03-10

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

Conditions

Helicobacter Infections, Resistance Bacterial, Gastritis H Pylori

Brief summary

The aim of this study is to determine the effectiveness of rifabutin triple therapy for the treatment of H. pylori infection in the Israeli population. Patients with or without a prior history of H. pylori eradication failure will be randomized to receive one of three possible treatments: Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care

Detailed description

Patients who present to the outpatient gastroenterology clinic at our institution with a positive diagnostic test for H pylori will be screened. Included patients will undergo randomisation into 3 groups. Randomization will be performed by a random sequence generator to create equal sized groups in boxes of 12. Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care Standard of care in previously untreated patients will consist of concomitant treatment (amoxicillin 1000mg, clarithromycin 500 mg, tinidazole 500 mg and esomeprazole all given twice daily for 14 days). In previously treated patients standard of care will consist of bismuth quadruple therapy, quinolone based therapy, or other susceptibility guided treatment where available. Treatment duration will be 14 days in all groups. Patients who are randomised to Group 3 and fail treatment will be offered open label rescue treatment with amoxicillin 1000mg bd, rifabutin 150 mg bd and esomeprazole 40 mg bd (14 days).

Interventions

DRUGRifabutin

150 mg

DRUGAmoxicillin

1000 mg

DRUGEsomeprazole

40 mg

DRUGClarithromycin

500 mg

500 mg

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized, open-label, non-blinded

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Patients presenting to outpatient clinic with evidence of H. pylori infection

Exclusion criteria

* allergy to any of the study drugs * prior exposure to rifamycin drugs * inability to provide informed consent * pregnancy or lactation * liver disease * haematological disease * renal failure * active malignancy * immune suppression * patients not expected to benefit from Helicobacter pylori eradication

Design outcomes

Primary

MeasureTime frameDescription
Success of H. pylori treatment6 weeks following end of treatmentNegative 13C-urea breath test or Helicobacter pylori Stool Ag

Secondary

MeasureTime frameDescription
Incidence of treatment-emergent adverse events14 days treatmentDaily entry of Likert scale (0-10) for the following parameters: diarrhea, nausea, abdominal pain, dyspepsia, reflux, loss of appetite, asthenia and others (free text). Adverse effects leading to treatment discontinuation. Serious adverse events leading to leading to patient's hospitalization, disability, or death, or to birth defects on pregnant patients
Compliance with H. pylori treatment14 days treatmentAssessed by diary entry twice daily. If more than 80% of pills taken, patient considered to be treatment compliant.

Contacts

Primary ContactDoron Boltin, MBBS
dboltin@gmail.com972504488881

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026