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Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

Sponsor
Rabin Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04652284
Collaborator
(none)
300
Enrollment
3
Arms
27
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, open-label, non-blindedRandomized, open-label, non-blinded
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Rifabutin Triple Therapy for First-line and Rescue Treatment of Helicobacter Pylori Infection
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rifabutin full dose

oral amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd 14 days

Drug: Rifabutin
150 mg
Other Names:
  • mycobutin®

    • Drug: Amoxicillin
    1000 mg
    Other Names:
  • Amoxil®

    • Drug: Esomeprazole
    40 mg
    Other Names:
  • "nexium"

    		•
    Active Comparator: Rifabutin low dose

    oral amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd 14 days

    Drug: Rifabutin
    150 mg
    Other Names:
  • mycobutin®

    • Drug: Amoxicillin
    1000 mg
    Other Names:
  • Amoxil®

    • Drug: Esomeprazole
    40 mg
    Other Names:
  • "nexium"

    		•
    Active Comparator: Standard of Care

    Standard of care in previously untreated patients will consist of concomitant treatment (oral amoxicillin 1000mg, clarithromycin 500 mg, tinidazole 500 mg and esomeprazole 40 mg 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

    Drug: Amoxicillin
    1000 mg
    Other Names:
  • Amoxil®

    • Drug: Esomeprazole
    40 mg
    Other Names:
  • "nexium"

    • Drug: Clarithromycin
    500 mg
    Other Names:
  • Biaxin®

    • Drug: Tinidazole
    500 mg
    Other Names:
  • protocide®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success of H. pylori treatment [6 weeks following end of treatment]

      Negative 13C-urea breath test or Helicobacter pylori Stool Ag

    Secondary Outcome Measures

    1. Incidence of treatment-emergent adverse events [14 days treatment]

      Daily 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

    2. Compliance with H. pylori treatment [14 days treatment]

      Assessed by diary entry twice daily. If more than 80% of pills taken, patient considered to be treatment compliant.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    • Principal Investigator: Doron Boltin, MBBS, Rabin Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT04652284
    Other Study ID Numbers:
    • 900-20-RMC
    First Posted:
    Dec 3, 2020
    Last Update Posted:
    Mar 10, 2021
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Infections
    Helicobacter Infections
    Gastritis
    Amoxicillin
    Clarithromycin
    Rifabutin
    Tinidazole
    Esomeprazole

    Study Results

    No Results Posted as of Mar 10, 2021