Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

Helicobacter Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04652284
• Other study ID #: 900-20-RMC
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2020
• Source: Rabin Medical Center
• Contact: Doron Boltin, MBBS
• Phone: 972504488881
• Email: dboltin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastritis
• Gastritis H Pylori
• Helicobacter Infections
• Infection
• Resistance Bacterial

Intervention

Drug:
• Rifabutin
150 mg
• Amoxicillin
1000 mg
• Esomeprazole
40 mg
• Clarithromycin
500 mg
• Tinidazole
500 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

References & Publications (4)

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. Erratum in: Alimen — View 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. 2020 Oct 10. doi: 10.1111/jgh.15294. [Epub ahead of p — View 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. E — View 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):5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of H. pylori treatment	Negative 13C-urea breath test or Helicobacter pylori Stool Ag	6 weeks following end of treatment
Secondary	Incidence of treatment-emergent adverse events	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	14 days treatment
Secondary	Compliance with H. pylori treatment	Assessed by diary entry twice daily. If more than 80% of pills taken, patient considered to be treatment compliant.	14 days treatment