Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/2133
Título : Daptomycin plus fosfomycin versus daptomycin monotherapy in treating MRSA: protocol of a multicentre, randomised, phase III trial.
Autor : Shaw, E
Miró, J M
Puig-Asensio, M
Pigrau, C
Barcenilla, F
Murillas, J
Garcia-Pardo, G
Espejo, E
Padilla, B
Garcia-Reyne, A
Pasquau, J
Rodriguez-Baño, J
López-Contreras, J
Montero, M
de la Calle, C
Pintado, V
Calbo, E
Gasch, O
Montejo, M
Salavert, M
Garcia-Pais, M J
Carratalà, J
Pujol, M
Filiación: [Shaw ,E; Carratalà,J; Pujol,M] Hospital Universitari de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain. [Miró,JM; de la Calle C] Hospital Universitari Clínic-IDIBAPS, Barcelona, Spain. [Puig-Asensio,M; Pigrau,C] Hospital Universitari Vall d'Hebron, Barcelona, Spain. [Barcenilla,F] Hospital Universitari Arnau de Vilanova, Lleida, Spain. [Murillas J] Hospital Universitari Son Espases, Mallorca, Spain. [Garcia-Pardo,G] Hospital Universitari Joan XXIII, Tarragona, Spain. [Espejo,E] Hospital Universitari de Terrassa, Terrassa, Barcelona, Spain. [Padilla,B] Hospital Universitario Gregorio Marañon, Madrid, Spain. [Garcia-Reyne,A] Hospital Universitario 12 de Octubre, Madrid, Spain. [Pasquau,J] Hospital Universitario Virgen de las Nieves, Granada, Spain. [Rodriguez-Baño,J] Hospital Universitario Virgen Macarena, Sevilla, Spain. [López-Contreras,J] Hospital Universitari Santa Creu i Sant Pau, Barcelona, Spain. [Montero,M] Hospital Universitari Parc de Salut Mar, Barcelona, Spain. [Pintado,V] Hospital Universitario Ramón y Cajal, Madrid, Spain. [Calbo,E] Hospital Universitari Mutúa de Terrassa, Barcelona, Spain. [Gasch,O] Corporació Sanitaria Parc Taulí, Sabadell, Barcelona, Spain. [Montejo,M] Hospital Universitario de Cruces, Barakaldo, Spain. [Salavert,M] Hospital Universitari i Politècnic la Fe, Valencia, Spain. [Garcia-Pais,MJ] Hospital Universitario Lucus Augusti, Lugo, Spain.
Grupo de Investigación: Spanish Network for Research in Infectious Diseases (REIPI RD12/0015);Instituto de Salud Carlos III, Madrid, Spain; GEIH (Hospital Infection Study Group)
Palabras clave : Adulto
Antibacterianos
Antibióticos Antituberculosos
Bacteriemia
Daptomicina
Humanos
Análisis de Intención de Tratar
Meticilina
Staphylococcus aureus Resistente a Meticilina
Recurrencia
España
Insuficiencia del Tratamiento
Resultado del Tratamiento
MeSH: Medical Subject Headings::Named Groups::Persons::Age Groups::Adult
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents::Antibiotics, Antitubercular
Medical Subject Headings::Diseases::Bacterial Infections and Mycoses::Bacterial Infections::Bacteremia
Medical Subject Headings::Chemicals and Drugs::Polycyclic Compounds::Macrocyclic Compounds::Peptides, Cyclic::Daptomycin
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic::Intention to Treat Analysis
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amides::Lactams::beta-Lactams::Penicillins::Methicillin
Medical Subject Headings::Organisms::Bacteria::Endospore-Forming Bacteria::Gram-Positive Endospore-Forming Bacteria::Gram-Positive Endospore-Forming Rods::Staphylococcaceae::Staphylococcus::Staphylococcus aureus::Methicillin-Resistant Staphylococcus aureus
Medical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Recurrence
Medical Subject Headings::Geographicals::Geographic Locations::Europe::Spain
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome::Treatment Failure
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome
Fecha de publicación : 2015
Editorial : BMJ Publishing Group
Cita Bibliográfica: Shaw E, Miró JM, Puig-Asensio M, Pigrau C, Barcenilla F, Murillas J, et al. Daptomycin plus fosfomycin versus daptomycin monotherapy in treating MRSA: protocol of a multicentre, randomised, phase III trial. BMJ Open. 2015; 5(3):e006723
Abstract: INTRODUCTION 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. METHODS AND ANALYSIS 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 day 7); (3) therapy is discontinued early due to adverse effects or for some other reason based on clinical judgement; (4) relapse of MRSA bacteraemia before the TOC visit; (5) death for any reason before the TOC visit. Assuming a 60% cure rate with daptomycin and a 20% difference in cure rates between the two groups, 103 patients will be needed for each group (α:0.05, ß: 0.2). Statistical analysis will be based on intention to treat, as well as per protocol and safety analysis. ETHICS AND DISSEMINATION The protocol was approved by the Spanish Medicines and Healthcare Products Regulatory Agency (AEMPS). The sponsor commits itself to publishing the data in first quartile peer-review journals within 12 months of the completion of the study. TRIAL REGISTRATION NUMBER NCT01898338.
Descripción : Journal Article; Research Support, Non-U.S. Gov't;
URI: http://hdl.handle.net/10668/2133
Versión del editor : http://bmjopen.bmj.com/content/5/3/e006723.abstract
DOI: 10.1136/bmjopen-2014-006723
ISSN : 2044-6055 (Online)
Appears in Collections:01- Artículos - Hospital Virgen Macarena
01- Artículos - Hospital Virgen de las Nieves

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