Clinical trial NCT04652284: Effectiveness of Rifabutin for Treatment of Helicobacter Pylori
Official title: Effectiveness of Rifabutin Triple Therapy for First-line and Rescue Treatment of Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Helicobacter Infections
Resistance Bacterial
Gastritis H Pylori
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label, non-blinded
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Success of H. pylori treatment
timeFrame: 6 weeks following end of treatment
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 14 days treatment
measure: Compliance with H. pylori treatment
timeFrame: 14 days treatment
Other outcomes:
Locations:
Study officials:
affiliation: Rabin Medical Center
name: Doron Boltin, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gingold-Belfer R, Niv Y, Levi Z, Boltin D. Rifabutin triple therapy for first-line and rescue treatment of Helicobacter pylori infection: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2021 Jun;36(6):1392-1402. doi: 10.1111/jgh.15294. Epub 2020 Oct 29.
citation: Graham DY, Canaan Y, Maher J, Wiener G, Hulten KG, Kalfus IN. Rifabutin-Based Triple Therapy (RHB-105) for Helicobacter pylori Eradication: A Double-Blind, Randomized, Controlled Trial. Ann Intern Med. 2020 Jun 16;172(12):795-802. doi: 10.7326/M19-3734. Epub 2020 May 5.
citation: Borody TJ, Pang G, Wettstein AR, Clancy R, Herdman K, Surace R, Llorente R, Ng C. Efficacy and safety of rifabutin-containing 'rescue therapy' for resistant Helicobacter pylori infection. Aliment Pharmacol Ther. 2006 Feb 15;23(4):481-8. doi: 10.1111/j.1365-2036.2006.02793.x.
citation: Perri F, Festa V, Clemente R, Villani MR, Quitadamo M, Caruso N, Bergoli ML, Andriulli A. Randomized study of two "rescue" therapies for Helicobacter pylori-infected patients after failure of standard triple therapies. Am J Gastroenterol. 2001 Jan;96(1):58-62. doi: 10.1111/j.1572-0241.2001.03452.x.