Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/2100
Título : Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial.
Autor : Rosso-Fernández, Clara
Sojo-Dorado, Jesús
Barriga, Angel
Lavín-Alconero, Lucía
Palacios, Zaira
López-Hernández, Inmaculada
Merino, Vicente
Camean, Manuel
Pascual, Alvaro
Rodríguez-Baño, Jesús
Filiación: [Rosso-Fernández,C; Barriga,A; Lavín-Alconero,L] Unidad de ensayos clínicos, Hospital Universitario Virgen del Rocío, Seville, Spain. [Rosso-Fernández,C] Farmacología Clínica, Hospital Universitario Virgen del Rocío, Seville, Spain. [Sojo-Dorado,J; Palacios,Z; López-Hernández,I; Pascual,A; Rodríguez-Baño,J] Unidad Clínica Intercentros de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospitales Universitarios Virgen Macarena y Virgen del Rocío, Seville, Spain. [Palacios,Z] Unidad Clínica de Medicina Interna, Hospital Universitario Virgen Macarena, Seville, Spain. [Merino,V; Camean,M] Unidad de Farmacia, Hospital Universitario Virgen Macarena, Seville, Spain. [Pascual,A] Departamento de Microbiología, Universidad de Sevilla, Seville, Spain. [Rodríguez-Baño,J] Departamento de Medicina, Universidad de Sevilla, Seville, Spain.
Grupo de Investigación: FOREST Study Group.
Palabras clave : Carbapenémicos
Antibacterianos
Bacteriemia
Investigación Biomédica
Fosfomicina
Tienamicinas
MeSH: Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents
Medical Subject Headings::Diseases::Bacterial Infections and Mycoses::Bacterial Infections::Bacteremia
Medical Subject Headings::Disciplines and Occupations::Natural Science Disciplines::Science::Research::Biomedical Research
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amides::Lactams::beta-Lactams::Carbapenems
Medical Subject Headings::Organisms::Bacteria::Gram-Negative Bacteria::Gram-Negative Facultatively Anaerobic Rods::Enterobacteriaceae::Escherichia::Escherichia coli
Medical Subject Headings::Humanities::Humanities::Ethics::Ethics Committees::Ethics Committees, Research
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Organophosphorus Compounds::Phosphonic Acids::Fosfomycin
Medical Subject Headings::Organisms::Bacteria::Gram-Negative Bacteria
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Health Care::Health Services Administration::Organization and Administration::Professional Practice::Referral and Consultation
Medical Subject Headings::Geographicals::Geographic Locations::Europe::Spain
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amides::Lactams::beta-Lactams::Carbapenems::Thienamycins
Medical Subject Headings::Diseases::Bacterial Infections and Mycoses::Infection::Urinary Tract Infections
Medical Subject Headings::Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Hydrolases::Amidohydrolases::beta-Lactamases
Fecha de publicación : 31-Mar-2015
Editorial : BMJ Publishing Group
Cita Bibliográfica: Rosso-Fernández C, Sojo-Dorado J, Barriga A, Lavín-Alconero L, Palacios Z, López-Hernández I, et al. Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial. BMJ Open. 2015; 5(3):e007363
Abstract: INTRODUCTION Finding therapeutic alternatives to carbapenems in infections caused by extended-spectrum β-lactamase-producing Escherichia coli (ESBL-EC) is imperative. Although fosfomycin was discovered more than 40 years ago, it was not investigated in accordance with current standards and so is not used in clinical practice except in desperate situations. It is one of the so-called neglected antibiotics of high potential interest for the future. METHODS AND ANALYSIS The main objective of this project is to demonstrate the clinical non-inferiority of intravenous fosfomycin with regard to meropenem for treating bacteraemic urinary tract infections (UTI) caused by ESBL-EC. This is a 'real practice' multicentre, open-label, phase III randomised controlled trial, designed to compare the clinical and microbiological efficacy, and safety of intravenous fosfomycin (4 g/6 h) and meropenem (1 g/8 h) as targeted therapy for this infection; a change to oral therapy is permitted after 5 days in both arms, in accordance with predetermined options. The study design follows the latest recommendations for designing trials investigating new options for multidrug-resistant bacteria. Secondary objectives include the study of fosfomycin concentrations in plasma and the impact of both drugs on intestinal colonisation by multidrug-resistant Gram-negative bacilli. ETHICS AND DISSEMINATION Ethical approval was obtained from the Andalusian Coordinating Institutional Review Board (IRB) for Biomedical Research (Referral Ethics Committee), which obtained approval from the local ethics committees at all participating sites in Spain (22 sites). Data will be presented at international conferences and published in peer-reviewed journals. DISCUSSION This project is proposed as an initial step in the investigation of an orphan antimicrobial of low cost with high potential as a therapeutic alternative in common infections such as UTI in selected patients. These results may have a major impact on the use of antibiotics and the development of new projects with this drug, whether as monotherapy or combination therapy. TRIAL REGISTRATION NUMBER NCT02142751. EudraCT no: 2013-002922-21. Protocol V.1.1 dated 14 March 2014.
Descripción : Journal Article; Research Support, Non-U.S. Gov't;
URI: http://hdl.handle.net/10668/2100
Versión del editor : http://bmjopen.bmj.com/content/5/3/e007363.abstract
DOI: 10.1136/bmjopen-2014-007363
ISSN : 2044-6055 (Online)
Appears in Collections:01- Artículos - Hospital Virgen del Rocío
01- Artículos - Hospital Virgen Macarena

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