drugset / Trial / NCT04652284
Effectiveness of Rifabutin for Treatment of Helicobacter Pylori
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2021-05-01
- Primary completion
- 2023-05-31
- Completion
- 2023-07-31
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |
| Comparator | Rifabutin | Small molecule | 150 mg | Oral |
| Comparator | tinidazole | Small molecule | 500 mg | Oral |
| Comparator | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Comparator | Esomeprazole | Small molecule | 40 mg | Oral |