Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection

Summary

Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.

Timeline

Start

2014-02

Primary completion

2015-03

Completion

2015-06

Publications

• Background Gisbert JP, Calvet X, Bermejo F, Boixeda D, Bory F, Bujanda L, Castro-Fernandez M, Dominguez-Munoz E, Elizalde JI, Forne M, Gene E, Gomollon F, Lanas A, Martin de Argila C, McNicholl AG, Mearin F, Molina-Infante J, Montoro M, Pajares JM, Perez-Aisa A, Perez-Trallero E, Sanchez-Delgado J. [III Spanish Consensus Conference on Helicobacter pylori infection]. Gastroenterol Hepatol. 2013 May;36(5):340-74. doi: 10.1016/j.gastrohep.2013.01.011. Epub 2013 Apr 18. No abstract available. Spanish.
• Background Gisbert JP, Pajares R, Pajares JM. Evolution of Helicobacter pylori therapy from a meta-analytical perspective. Helicobacter. 2007 Nov;12 Suppl 2:50-8. doi: 10.1111/j.1523-5378.2007.00576.x.
• Background Graham DY. Helicobacter pylori eradication therapy research: Ethical issues and description of results. Clin Gastroenterol Hepatol. 2010 Dec;8(12):1032-6. doi: 10.1016/j.cgh.2010.07.002. Epub 2010 Jul 23.
• Background Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.
• Background Hawkey CJ, Atherton JC, Treichel HC, Thjodleifsson B, Ravic M. Safety and efficacy of 7-day rabeprazole- and omeprazole-based triple therapy regimens for the eradication of Helicobacter pylori in patients with documented peptic ulcer disease. Aliment Pharmacol Ther. 2003 Apr;17(8):1065-74. doi: 10.1046/j.1365-2036.2003.01492.x.
• Background Paoluzi P, Iacopini F, Crispino P, Nardi F, Bella A, Rivera M, Rossi P, Gurnari M, Caracciolo F, Zippi M, Pica R. 2-week triple therapy for Helicobacter pylori infection is better than 1-week in clinical practice: a large prospective single-center randomized study. Helicobacter. 2006 Dec;11(6):562-8. doi: 10.1111/j.1523-5378.2006.00459.x.
• Background Veldhuyzen Van Zanten S, Machado S, Lee J. One-week triple therapy with esomeprazole, clarithromycin and metronidazole provides effective eradication of Helicobacter pylori infection. Aliment Pharmacol Ther. 2003 Jun 1;17(11):1381-7. doi: 10.1046/j.1365-2036.2003.01554.x.
• Background Vakil N, Lanza F, Schwartz H, Barth J. Seven-day therapy for Helicobacter pylori in the United States. Aliment Pharmacol Ther. 2004 Jul 1;20(1):99-107. doi: 10.1111/j.1365-2036.2004.02029.x.
• Background Laine L, Fennerty MB, Osato M, Sugg J, Suchower L, Probst P, Levine JG. Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials. Am J Gastroenterol. 2000 Dec;95(12):3393-8. doi: 10.1111/j.1572-0241.2000.03349.x.
• Background Laine L, Suchower L, Frantz J, Connors A, Neil G. Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials. Am J Gastroenterol. 1998 Nov;93(11):2106-12. doi: 10.1111/j.1572-0241.1998.00602.x.
• Background Calvet X, Ducons J, Bujanda L, Bory F, Montserrat A, Gisbert JP; Hp Study Group of the Asociacion Espanola de Gastroenterologia. Seven versus ten days of rabeprazole triple therapy for Helicobacter pylori eradication: a multicenter randomized trial. Am J Gastroenterol. 2005 Aug;100(8):1696-701. doi: 10.1111/j.1572-0241.2005.50019.x.
• Background Gisbert JP, Dominguez-Munoz A, Dominguez-Martin A, Gisbert JL, Marcos S. Esomeprazole-based therapy in Helicobacter pylori eradication: any effect by increasing the dose of esomeprazole or prolonging the treatment? Am J Gastroenterol. 2005 Sep;100(9):1935-40. doi: 10.1111/j.1572-0241.2005.00178.x.
• Background Della Monica P, Lavagna A, Masoero G, Lombardo L, Crocella L, Pera A. Effectiveness of Helicobacter pylori eradication treatments in a primary care setting in Italy. Aliment Pharmacol Ther. 2002 Jul;16(7):1269-75. doi: 10.1046/j.1365-2036.2002.01244.x.
• Background Altintas E, Sezgin O, Ulu O, Aydin O, Camdeviren H. Maastricht II treatment scheme and efficacy of different proton pump inhibitors in eradicating Helicobacter pylori. World J Gastroenterol. 2004 Jun 1;10(11):1656-8. doi: 10.3748/wjg.v10.i11.1656.
• Background Gumurdulu Y, Serin E, Ozer B, Kayaselcuk F, Ozsahin K, Cosar AM, Gursoy M, Gur G, Yilmaz U, Boyacioglu S. Low eradication rate of Helicobacter pylori with triple 7-14 days and quadriple therapy in Turkey. World J Gastroenterol. 2004 Mar 1;10(5):668-71. doi: 10.3748/wjg.v10.i5.668.
• Background Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. Am J Gastroenterol. 1998 Dec;93(12):2330-8. doi: 10.1111/j.1572-0241.1998.00684.x. No abstract available.
• Background Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
• Background Egan BJ, Marzio L, O'Connor H, O'Morain C. Treatment of Helicobacter pylori infection. Helicobacter. 2008 Oct;13 Suppl 1:35-40. doi: 10.1111/j.1523-5378.2008.00639.x.
• Background Yakoob J, Abid S, Abbas Z, Jafri SN. Antibiotic susceptibility patterns of Helicobacter pylori and triple therapy in a high-prevalence area. Br J Biomed Sci. 2010;67(4):197-201. doi: 10.1080/09674845.2010.11730319.
• Background Vakil N, Hahn B, McSorley D. Clarithromycin-resistant Helicobacter pylori in patients with duodenal ulcer in the United States. Am J Gastroenterol. 1998 Sep;93(9):1432-5. doi: 10.1111/j.1572-0241.1998.455_t.x.

Drugs

Indications