Jesús Rodríguez-Baño

Instituto de Salud Carlos III, Madrid, Madrid, Spain

Are you Jesús Rodríguez-Baño?

Claim your profile

Publications (242)915.93 Total impact

  • Journal of Antimicrobial Chemotherapy 07/2015; DOI:10.1093/jac/dkv187 · 5.44 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The aim of this study was to improve the understanding of the pharmacokinetic-pharmacodynamic relationships of fosfomycin against ESBL-producing E. coli with differing fosfomycin MIC values. A hollow-fiber infection model with three clinical ESBL- producing E. coli was used. Human-like fosfomycin pharmacokinetic profiles were simulated over 4 days. Dose-finding and mutant suppression dose-range studies were conducted, using regimens from 12g/day to 36g/day. The combination of fosfomycin 4g/q8h and meropenem 1g/q8h was assessed. Total bacterial population and resistant subpopulations were determined. No efficacy was observed against the Ec42444 strain (fosfomycin MIC = 64mg/l) using 12, 24 or 36g/day.All dosages induced at least initial bacterial killing against Ec46 (fosfomycin MIC=1mg/l). High-level drug resistant mutants appeared after 12, 15, and 18g/day. In the arms of 24g/day, once and in a divided dose, a complete extinction of the bacterial inoculum was observed.The combination meropenem with fosfomycin was synergistic for bacterial kill, and also suppressed all fosfomycin-resistant clones against Ec2974 (fosfomycin MIC=1mg/l). Fosfomycin susceptibility breakpoints (≤64 mg/l in CLSI for E. coli urinary tract infections only) should be revised for the treatment of serious systemic infections; fosfomycin can be used to treat infections only with lower MICs and lower bacterial densities, although relatively high daily dosages (i.e. 24g/day) are required to prevent the emergence of bacterial resistance; the fAUC/MIC appears to be the dynamically-linked index for the suppression of bacterial resistance. Fosfomycin with meropenem is synergistic for this E. coli isolate preventing the emergence of fosfomycin resistance. Copyright © 2015, American Society for Microbiology. All Rights Reserved.
    Antimicrobial Agents and Chemotherapy 06/2015; DOI:10.1128/AAC.00752-15 · 4.45 Impact Factor
  • Jesús Rodríguez-Baño
    [Show abstract] [Hide abstract]
    ABSTRACT: Several antimicrobial agents are being investigated as alternatives to carbapenems in the treatment of infections caused by ESBL-producing Enterobacteriaceae, which may be useful in avoiding overuse of carbapenems in the context of recent global spread of carbapenem-resistant Enterobacteriaceae. The most promising candidates for invasive infections so far are β-lactam/β-lactam inhibitor combinations and cephamycins. Copyright © 2015, American Society for Microbiology. All Rights Reserved.
    Antimicrobial Agents and Chemotherapy 06/2015; DOI:10.1128/AAC.01333-15 · 4.45 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Introducción y objetivos: El objetivo del estudio es validar la capacidad de predicción de mortalidad en distintos tiempos de las definiciones de infección por Clostridium difficile (ICD) grave de la SHEA- IDSA y de la ESCMID. Material y métodos: Estudio observacional y retrospectivo de los casos consecutivos de ICD ocurridos en un hospital universitario con 950 camas entre marzo de 2008 y julio de 2014. Se han considerado como casos de ICD aquellos pacientes con un cuadro clínico compatible y resultado microbiológico positivo en heces (detección de toxina por EIA o detección de C. difficile toxigénico mediante PCR). Los datos han sido extraídos revisando la historia clínica de todos los casos. Se ha analizado si las definiciones de ICD grave de la SHEA- IDSA (aumento ≥ 50% en creatinemia basal, leucocitosis > 15.000 cel/µL, hipotensión o presencia de complicaciones: íleo paralitico, edema de pared, dilatación colónica > 6 cm) y de la ESCMID (fiebre > 38,5 o C, inestabilidad hemodinámica, necesidad de ventilación mecánica, aumento ≥ 50% en creatinemia basal, leucocitosis > 15.000 cel/µL o > 25% de neutrófilos, albumina < 3,0 mg/dl, colitis pseudomenbranosa en la colonoscopia, ácido láctico > 5 mM/L y complicaciones (ídem a SHEA más peritonismo y rarefacción de la grasa colónica) eran predictores de mortalidad en distintos tiempos de seguimiento. Se realizo el análisis estadístico con el programa SPSS 15.0. Se incluyeron 150 casos, de edad media 73 años, y 44% hombres; 65 casos (43%) presentaban un índice de Charlson > 2 y 114 (66%) se clasificaron como de adquisición nosocomial. La mortalidad fue del 8%, 20,7%, 28,7% y 34,7% a los 7, 30, 90 días y un año, respectivamente. La asociación entre los criterios de SHEA-IDSA y ESCMID y mortalidad se muestra en la tabla. Controlando por edad y Charlson, la OR ajustada (IC95%) para la mortalidad del criterio de gravedad de SHEA-IDSA fue de 1,88 (0,77-4,56), 1,66 (0,72-3,83) y 1,38 (0,60-3,16) para mortalidad en los días 30, 90 y 1 año; para el criterio de gravedad de ESCMID fueron fue de 1,96 (0,72-5,34), 2,34 (0,94-5,82) y 2,07 (0,89-4,81) para mortalidad en los días 30, 90 y 1 año. Conclusiones: La presencia de criterios de la SHEA-IDSA y ESCMID se asociaron con un mayor riesgo de muerte a partir de los 90 días en el análisis crudo; los criterios de la SHEA-IDSA además fueron predictores de la mortalidad en el día 30. Sin embargo, ninguno de ellos fue predictor de mortalidad controlando por variables clave.
    XIX Congreso Sociedad Española de Enfermedades Infecciosas, Sevilla, España; 05/2015
  • [Show abstract] [Hide abstract]
    ABSTRACT: To assess the current clinical features and determinants of outcome of Candida tropicalis bloodstream infection (BSI). A population-based surveillance on Candida BSI was conducted from May 2010 to April 2011 in 29 Spanish hospitals. Antifungal susceptibility testing (EUCAST methodology) was centrally performed. The characteristics and outcome of C. tropicalis BSI episodes were compared with those due to other species. Fifty-nine out of 752 episodes (7.8%) were due to C. tropicalis (annual incidence: 0.62 cases per 100,000 population). Resistance to fluconazole and voriconazole was found in 23.2% and 26.8% of isolates. Breakthrough BSI occurred in 10.5% of episodes. Risk factors for C. tropicalis BSI were age (odds ratio [OR]: 1.01; P-value = 0.05), underlying leukaemia (OR: 4.77; P-value = 0.001) and chronic lung disease (OR: 2.62; P-value = 0.002). There were no differences in clinical failure (persistent BSI for ≥72 hours after initiation of therapy and/or 30-day all-cause mortality) between C. tropicalis (39.6%) and non-C. tropicalis groups (45.6%). The appropriateness of antifungal therapy or the fluconazole MIC values had no significant impact on outcome, whereas early central venous catheter removal exerted a protective effect. C. tropicalis BSI was associated with advanced age, haematological malignancy and respiratory comorbidity. We found no correlation between the unexpectedly high resistance rate to azoles observed and outcome. Copyright © 2015. Published by Elsevier Ltd.
    The Journal of infection 05/2015; DOI:10.1016/j.jinf.2015.05.009 · 4.02 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The known data about the influence of vancomycin MIC on Staphylococcus aureus bacteraemia are contradictory. Our objective was to study the possible impact of vancomycin MIC ≥1.5 mg/L on short- and medium-term mortality. A prospective cohort study was carried out from March 2008 to January 2011 on adult patients with MSSA bacteraemia admitted to a tertiary hospital located in Seville (Spain). We studied the relationship between vancomycin MIC, accessory gene regulator (agr) type and absence of δ-haemolysin and poor prognosis. All isolates were genotyped by PFGE. Multivariate analysis, including a propensity score for having a vancomycin MIC of ≥1.5 mg/L, was performed by Cox regression. One hundred and thirty-five episodes of bacteraemia due to MSSA were included in the analysis. Twenty-nine (21.5%) isolates had a vancomycin MIC of ≥1.5 mg/L by Etest. There were no differences in agr distribution or absence of δ-haemolysin between isolates with reduced vancomycin susceptibility (RVS) and those without. RVS was not more frequent in specific clones; RVS was not associated with higher 14 or 30 day crude mortality (relative risk = 0.44, 95% CI = 0.14-1.35; and relative risk = 1.01, 95% CI = 0.52-1.96) rates, and it did not show higher rates of complicated bacteraemia (14.2% versus 13.8%, P = 0.61). Cox regression analysis did not significantly modify the results for 14 day mortality (HR = 0.39, 95% CI = 0.11-1.34) or 30 day mortality (HR = 0.89, 95% CI = 0.39-2.04). Contrary to previously published data, we did not find a relationship between RVS and higher mortality in patients with MSSA bacteraemia and we did not find a link with higher complicated bacteraemia rates. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
    Journal of Antimicrobial Chemotherapy 05/2015; DOI:10.1093/jac/dkv133 · 5.44 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The spread of multidrug-resistant Enterobacteriaceae related to the production of extended-spectrum β-lactamases and carbapenemases is a serious public health problem worldwide. Microbiological diagnosis and therapy of these infections are challenging and controversial. Clinically relevant questions were selected and the literature was reviewed for each of them. The information from the selected articles was extracted and recommendations were provided and graded according to the strength of the recommendations and quality of the evidence. The document was opened to comments from the members from the Spanish Society of Infectious Diseases and Clinical Microbiology, which were considered for inclusion in the final version. Evidence-based recommendations are provided for the use of microbiological techniques for the detection of extended-spectrum β-lactamases and carbapenemases in Enterobacteriaceae, and for antibiotic therapy for invasive/severe infections caused by these organisms. The absence of randomised controlled trials is noteworthy; thus, recommendations are mainly based on observational studies (that have important methodological limitations), pharmacokinetic and pharmacodynamics models, and data from animal studies. Additionally, areas for future research were identified.
    Enfermedades Infecciosas y Microbiología Clínica 05/2015; DOI:10.1016/j.eimc.2014.11.009 · 1.88 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Both bacteremia and infective endocarditis caused by Staphylococcus aureus are common and severe diseases. The prognosis may darken not infrequently, especially in the presence of intracardiac devices or methicillin-resistance. Indeed, the optimization of the antimicrobial therapy is a key step in the outcome of these infections. The high rates of treatment failure and the increasing interest in the influence of vancomycin susceptibility in the outcome of infections caused by both methicillin-susceptible and -resistant isolates has led to the research of novel therapeutic schemes. Specifically, the interest raised in recent years on the new antimicrobials with activity against methicillin-resistant staphylococci has been also extended to infections caused by susceptible strains, which still carry the most important burden of infection. Recent clinical and experimental research has focused in the activity of new combinations of antimicrobials, their indication and role still being debatable. Also, the impact of an appropriate empirical antimicrobial treatment has acquired relevance in recent years. Finally, it is noteworthy the impact of the implementation of a systematic bundle of measures for improving the outcome. The aim of this clinical guideline is to provide an ensemble of recommendations in order to improve the treatment and prognosis of bacteremia and infective endocarditis caused by S. aureus, in accordance to the latest evidence published. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.
    Enfermedades Infecciosas y Microbiología Clínica 04/2015; DOI:10.1016/j.eimc.2015.03.015 · 1.88 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Bacteremia and infective endocarditis caused by Staphylococcus aureus are common and severe diseases. Optimization of treatment is fundamental in the prognosis of these infections. The high rates of treatment failure and the increasing interest in the influence of vancomycin susceptibility in the outcome of infections caused by both methicillin-susceptible and -resistant isolates have led to research on novel therapeutic schemes. The interest in the new antimicrobials with activity against methicillin-resistant staphylococci has been extended to susceptible strains, which still carry the most important burden of infection. New combinations of antimicrobials have been investigated in experimental and clinical studies, but their role is still being debated. Also, the appropriateness of the initial empirical therapy has acquired relevance in recent years. The aim of this guideline is to update the 2009 guidelines and to provide an ensemble of recommendations in order to improve the treatment of staphylococcal bacteremia and infective endocarditis, in accordance with the latest published evidence. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.
    Enfermedades Infecciosas y Microbiología Clínica 04/2015; DOI:10.1016/j.eimc.2015.03.014 · 1.88 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background and objectives: Among patients with bacteraemia due to S. aureus, persistence of positive blood cultures after 2-3 days of active therapy (persistent bacteraemia or PB) is considered a marker for complicated SAB. PB may be related bacterial determinants, hosts' features, or clinical management. The aim of this analysis is to investigate the hosts' and management variables associated to PB despite an adequate targeted therapy and early source control. Methods: Prospective cohort of SAB from 12 tertiary Spanish hospitals between 2008 and 2011. Two analyses were performed; (a) including only patients in whom follow-up blood cultures (FUBC) were performed 48-72 hours after start of active therapy; and (b) including all patients with SAB (those without FUBC were considered not to have PB). Those cases who died before 72 hours and those receiving palliative care for terminal conditions were excluded. Univariate analyses were performed by Chi-square test, and multivariate analyses by logistic regression. Results: 292 of the 496 (58.9%) included patients had FUBC; of them, 91 (31.2%) had PB. In the univariate analysis, PB was associated with high 14-day (RR 1.74; 95% CI 0.93-3.25, p= 0.08) and 30-day crude mortality (RR 1.77; 95% CI 1.03-3.01, p= 0.04). The variables associated with PB in multivariate analysis were a Pitt score >2 (OR 2.69; 95% CI: 1.13-6.37, p=0.03), skin and soft tissue infection as a source (OR 2.75; 95% CI: 0.87-8.65, p=0.08), and presence of septic metastasis (OR 3.45; 95% CI: 1.00-11.83, p=0.05). MRSA, early active therapy, and early source control were not associated. Among the whole series of patients with SAB (n=496), the variables associated with PB in multivariate analysis were a Pitt score >2 (OR 3.43; 95% CI: 1.62-7.27, p=0.001), skin and soft tissue infection as a source (OR 3.76; 95% CI: 1.35-10.46, p=0.01), presence of septic metastasis (OR 2.42; 95% CI: 0.90-6.46, p=0.08), and endocarditis diagnosis during the course of the SAB (OR 2.60; 95% CI: 0.99-6.84, p=0.05). Conclusion: The frequency of PB was high. The clinical variables associated with PB at the diagnosis were the severity of illness assessed by Pitt score and the skin and soft tissue source. The presence or development of septic metastasis during the bacteraemia and infectious endocarditis were also associated. It is crucial to performance FUBC because the presence of PB has clinical management and prognosis implications.
    25th European Congress of Clinical Microbriology and Infectious Diseases, Copenhagen, Denmark; 04/2015
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: In the last decade we have witnessed a dramatic increase in the proportion and absolute number of bacterial pathogens resistant to multiple antibacterial agents. Multidrug-resistant bacteria are currently considered as an emergent global disease and a major public health problem. The B-Debate meeting brought together renowned experts representing the main stakeholders (i.e. policy makers, public health authorities, regulatory agencies, pharmaceutical companies, and the scientific community at large) to review the global threat of antibiotic resistance and come up with a coordinated set of strategies to fight antimicrobial resistance in a multifaceted approach. The present article summarises the views of the B-debate participants regarding the current situation of antimicrobial resistance in animals and the food chain, within the community and the health-care setting as well as the role of the environment and the development of novel diagnostic and therapeutic strategies, providing expert recommendations to tackle the global threat of antimicrobial resistance.
    04/2015; 6. DOI:10.1016/j.nmni.2015.02.007
  • [Show abstract] [Hide abstract]
    ABSTRACT: The aim of this study was to determine the impact of the carbapenemase-producing Enterobacteriaceae (CPE) in Spain in 2013 by describing their prevalence, dissemination and geographic distribution of CPE clones, their population structure and antibiotic susceptibility. From February 2013 to May 2013, 83 hospitals (about 40,000 hospital beds) prospectively collected non-duplicate Enterobacteriaceae using the screening cut-off recommended by EUCAST. Carbapenemase characterisation was performed by phenotypic methods and confirmed by PCR and sequencing. MLST types were determined for Klebsiella pneumoniae and Escherichia coli. A total of 702 Enterobacteriaceae isolates met the inclusion criteria; 379 (54%) were CPE. OXA-48 (71.5%) and VIM-1 (25.3%) were the most frequent carbapenemases, and K. pneumoniae (74.4%), Enterobacter cloacae (10.3%), and E. coli (8.4%) were the species most affected. Susceptibility to colistin, amikacin and meropenem was 95.5%, 81.3%, and 74.7%, respectively. The most prevalent STs were ST11 and ST405 in K. pneumoniae, and ST131 in E. coli. Forty-five (54.1%) of the hospitals had at least one CPE case. In K. pneumoniae, ST11/OXA-48, ST15/OXA-48, ST405/OXA-48, and ST11/VIM-1 were detected in two or more Spanish provinces. ST11 carried four carbapenemases (VIM-1, OXA-48, KPC-2, and OXA-245), but ST405 carried OXA-48 only. A wide interregional spread of CPE in Spain was observed mainly due to a few successful clones of OXA-48-producing K. pneumoniae (e.g. ST11 and ST405). Dissemination of OXA-48-producing E. coli is a new finding of public health concern. According to in vitro susceptibilities, most of the CPE (94.5%) had three or more options of antibiotic treatment. Copyright © 2015, American Society for Microbiology. All Rights Reserved.
    Antimicrobial Agents and Chemotherapy 03/2015; 59(6). DOI:10.1128/AAC.00086-15 · 4.45 Impact Factor
  • Juan Gálvez-Acebal · Manuel Almendro-Delia · Jesús Rodriguez-Baño
    Mayo Clinic Proceedings 03/2015; 90(3):415-416. DOI:10.1016/j.mayocp.2014.12.017 · 5.81 Impact Factor
  • Juan Gálvez-Acebal · Manuel Almendro-Delia · Jesús Rodriguez-Baño
    Mayo Clinic Proceedings 03/2015; 90(3):415-416. · 5.81 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    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 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. 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. NCT01898338. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
    BMJ Open 03/2015; 5(3):e006723. DOI:10.1136/bmjopen-2014-006723 · 2.06 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: A matched case-control study and a qualitative investigation were used to identify adverse events in diverse dimensions associated with isolation. Overall satisfaction with care was similar among patients in isolation, but staff was found to be less responsive. Isolation was also associated with depression, but not with increased anxiety. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
    American Journal of Infection Control 02/2015; 43(4). DOI:10.1016/j.ajic.2015.01.009 · 2.33 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Extraintestinal pathogenic Escherichia coli (ExPEC) are among the most frequently isolated bacterial pathogens in hospitals. They are considered opportunistic pathogens and are found mostly in urinary and bloodstream infections. They are genetically diverse, and many studies have sought associations between genotypes or virulence genes and infection site, severity, or outcome, with varied, often contradictory, results. To understand these difficulties, we have analyzed the diversity patterns in the core genomes and virulomes of more than 500 ExPEC isolates from 5 different collections. The core genome was analyzed using a multilocus sequence type-based single-nucleotide polymorphism (SNP) pyrosequencing approach, while the virulence gene content (the virulome) was studied by polymerase chain reaction detection of 25 representative genes. SNP typing showed a similar population structure in the different collections: half of the isolates belong to a few sequence types (5 to 8), while the other half is composed of a large diversity of sequence types that are found once or twice. Sampling analysis by rarefaction plots of SNP profiles showed saturation curves indicative of a limited diversity. Contrary to this, the virulome shows an extremely high diversity, with almost as many gene profiles as isolates, and linear, nonsaturating, rarefaction plots, even within sequence types. These data show that genetic exchange rates are very heterogeneous along the chromosome, being much higher in the virulome fraction of the genome than in the core genome.
    Canadian Journal of Microbiology 02/2015; DOI:10.1139/cjm-2014-0835 · 1.18 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The spread of multidrug-resistant Enterobacteriaceae related to the production of extended-spectrum β-lactamases (ESBL) and carbapenemases is a serious public health problem worldwide. Microbiological diagnosis and therapy of these infections are challenging and controversial. After the selection of clinically relevant questions, this document provides evidence-based recommendations for the use of microbiological techniques for the detection of ESBL- and carbapenemase-producing Enterobacteriaceae, and for antibiotic therapy for invasive infections caused by these organisms. The absence of randomized-controlled trials is noteworthy, thus recommendations are mainly based on observational studies, that have important methodological limitations, pharmacokinetic and pharmacodynamics models, and data from animal studies. Additionally, areas for future research were identified. Copyright © 2014. Published by Elsevier España.
    Enfermedades Infecciosas y Microbiología Clínica 01/2015; 33(5). DOI:10.1016/j.eimc.2014.11.015 · 1.88 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: 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. 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. 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. 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. NCT02142751. EudraCT no: 2013-002922-21. Protocol V.1.1 dated 14 March 2014. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
    BMJ Open 01/2015; 5(3):e007363. DOI:10.1136/bmjopen-2014-007363 · 2.06 Impact Factor

Publication Stats

4k Citations
915.93 Total Impact Points

Institutions

  • 2012–2015
    • Instituto de Salud Carlos III
      Madrid, Madrid, Spain
  • 2003–2015
    • Universidad de Sevilla
      • • Medicine
      • • Departamento de Microbiología
      Hispalis, Andalusia, Spain
  • 1997–2015
    • Hospital Universitario Virgen Macarena
      Hispalis, Andalusia, Spain
  • 2013
    • University Hospital Vall d'Hebron
      Barcino, Catalonia, Spain
  • 2010
    • Hospital Universitario de Getafe
      Madrid, Madrid, Spain
    • Hospital Universitario Puerta de Hierro-Majadahonda
      Махадаонда, Madrid, Spain
    • Hospital Son Dureta
      Palma, Balearic Islands, Spain
  • 2004–2010
    • Hospital Clínic de Barcelona
      • Servicio de Microbiología
      Barcino, Catalonia, Spain
  • 2009
    • Complejo Hospitalario Universitario a Coruña (CHUAC)
      La Corogne, Galicia, Spain