Daptomycin plus fosfomycin versus daptomycin monotherapy in treating MRSA: protocol of a multicentre, randomised, phase III trial

BMJ Open
E ShawGEIH (Hospital Infection Study Group)

Abstract

Despite the availability of new antibiotics such as daptomycin, methicillin-resistant Staphylococcus aureus (MRSA) bacteraemia continues to be associated with high clinical failure rates. Combination therapy has been proposed as an alternative to improve outcomes but there is a lack of clinical studies. The study aims to demonstrate that combination of daptomycin plus fosfomycin achieves higher clinical success rates in the treatment of MRSA bacteraemia than daptomycin alone. A multicentre open-label, randomised phase III study. Adult patients hospitalised with MRSA bacteraemia will be randomly assigned (1:1) to group 1: daptomycin 10 mg/kg/24 h intravenous; or group 2: daptomycin 10 mg/kg/24 h intravenous plus fosfomycin 2 gr/6 g intravenous. The main outcome will be treatment response at week 6 after stopping therapy (test-of-cure (TOC) visit). This is a composite variable with two values: Treatment success: resolution of clinical signs and symptoms (clinical success) and negative blood cultures (microbiological success) at the TOC visit. Treatment failure: if any of the following conditions apply: (1) lack of clinical improvement at 72 h or more after starting therapy; (2) persistent bacteraemia (positive blood cultures on d...Continue Reading

References

Dec 20, 2002·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Sara E CosgroveYehuda Carmeli
Aug 18, 2006·The New England Journal of Medicine·Vance G FowlerUNKNOWN S. aureus Endocarditis and Bacteremia Study Group
Jan 4, 2008·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Alex SorianoJosep Mensa
Mar 4, 2009·Enfermedades infecciosas y microbiología clínica·Francisco GudiolUNKNOWN Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica
Jul 22, 2009·Antimicrobial Agents and Chemotherapy·J M MiróUNKNOWN Hospital Clinic Experimental Endocarditis Study Group
Nov 17, 2009·European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology·M PopovicC Joukhadar
Feb 27, 2010·European Journal of Clinical Pharmacology·Antonia C KastorisMatthew E Falagas
Jan 11, 2011·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Catherine LiuHenry F Chambers
May 10, 2011·International Journal of Antimicrobial Agents·Gary WuEric Balmir
Jun 22, 2011·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Abhay DhandGeorge Sakoulas
Feb 4, 2012·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·S J van HalD L Paterson
May 31, 2012·Antimicrobial Agents and Chemotherapy·José M MiróUNKNOWN Hospital Clinic Experimental Endocarditis Study Group
Jan 22, 2013·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·O GaschUNKNOWN REIPI/GEIH Study Groups

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Citations

Sep 1, 2015·Journal of the American College of Cardiology·J Alberto San RománCristina Sarriá
Jun 13, 2015·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Matthew E Falagas, Petros I Rafailidis
Apr 14, 2016·Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy·Alison S VanEperen, John Segreti
Dec 14, 2016·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·B GrabeinD B Liesenfeld
Jul 25, 2017·Journal of Global Antimicrobial Resistance·Gulseren Aktas, Sengul Derbentli
Nov 9, 2017·Expert Opinion on Pharmacotherapy·Carlota GudiolJordi Carratalà
Jul 16, 2020·Microbial Drug Resistance : MDR : Mechanisms, Epidemiology, and Disease·Lin ChenGuoqiang Zhu
Jul 14, 2018·Journal of Clinical Pharmacy and Therapeutics·Paul O LewisDavid B Cluck
Sep 14, 2017·Expert Review of Anti-infective Therapy·Andrew F ShorrJohn F Mohr
Jul 30, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Miquel PujolUNKNOWN MRSA Bacteremia (BACSARM) Trial Investigators
Nov 18, 2020·Deutsche medizinische Wochenschrift·Annette Hennigs, Johannes Jochum
Jan 20, 2021·Diagnostic Microbiology and Infectious Disease·Alessandro BondiRossana Cavallo
Mar 11, 2016·Clinical Microbiology Reviews·Matthew E FalagasKonstantinos Z Vardakas

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