{
    "abstract": "We assessed the effectiveness and safety of cefiderocol in patients with Gram-negative bacterial infections, excluding Acinetobacter spp., in the early access programme (EAP) in Spain.\nThe retrospective, multicentre PERSEUS study (2018-2022) enrolled hospitalised patients with serious Gram-negative infections, except Acinetobacter spp., who received first-time cefiderocol for \u2265\u200972\u00a0h following requests through the EAP. Clinical cure at end of treatment, all-cause mortality at Day 28, cefiderocol use, and adverse drug reactions (ADRs) were the key outcomes.\nOverall, 261 patients were eligible for analysis. Median (interquartile range) age was 61 (49-68) years, 202 (77.4%) were male and 165 (63.2%) were in the intensive care unit. The most frequent diagnoses were respiratory tract infection (47.9%), intra-abdominal infection (14.6%), and urinary tract infection (14.6%). The median (IQR) duration of cefiderocol treatment was 10 (7-14) days. Overall, the clinical cure rate was 80.5% (210/261) and the 28-day mortality rate was 21.5% (56/261). In patients with Pseudomonas aeruginosa infection (66.7% [n\u2009=\u2009174], including 73 [42%] with metallo-\u03b2-lactamases), the clinical cure rate was 84.5% (147/174) and the 28-day mortality was 17.2% (30/174). Logistic regression analysis showed that prior antibiotic treatment for >\u20097 days (OR 0.19, 95% CI 0.05-0.56) and mechanical ventilation (OR 0.32, 95% CI 0.15-0.67) were independent negative predictive factors for clinical cure. ADRs occurred in seven patients, six events resolved, and one was fatal (toxic epidermal necrolysis).\nCefiderocol is a valuable option in the treatment of serious Gram-negative bacterial infections, particularly for those caused by P. aeruginosa.\nGOV: NCT05789199 (Registration date: 16 February 2023).",
    "authors": [
        {
            "affiliation": "Maim\u00f3nides Biomedical Research Institute of C\u00f3rdoba (IMIBIC), Reina Sofia University Hospital of C\u00f3rdoba, C\u00f3rdoba, Spain.\nCentro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.\nInfectious Diseases Service, Reina Sofia University Hospital of C\u00f3rdoba, C\u00f3rdoba, Spain.\nDepartment of Medical and Surgical Sciences, University of C\u00f3rdoba, C\u00f3rdoba, Spain.",
            "firstname": "Julian",
            "initials": "J",
            "lastname": "Torre-Cisneros"
        },
        {
            "affiliation": "Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.\nInfectious Diseases Department, Hospital Universitario Vall d' Hebr\u00f3n, Barcelona, Spain.",
            "firstname": "Benito",
            "initials": "B",
            "lastname": "Almirante"
        },
        {
            "affiliation": "Maim\u00f3nides Biomedical Research Institute of C\u00f3rdoba (IMIBIC), Reina Sofia University Hospital of C\u00f3rdoba, C\u00f3rdoba, Spain.\nCentro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.\nCritical Care Service, Hospital Universitario Reina Sof\u00eda, C\u00f3rdoba, Spain.",
            "firstname": "Carmen De La Fuente",
            "initials": "CF",
            "lastname": "Martos"
        },
        {
            "affiliation": "Intensive Care Unit, Complejo Hospitalario Universitario Santiago de Compostela, Santiago de Compostela, Spain.",
            "firstname": "Pedro",
            "initials": "P",
            "lastname": "Rascado"
        },
        {
            "affiliation": "Infectious Diseases Unit, Medical Clinic Department, Hospital Universitario y Polit\u00e9cnico La Fe, Valencia, Spain.",
            "firstname": "Miguel Salavert",
            "initials": "MS",
            "lastname": "Llet\u00ed"
        },
        {
            "affiliation": "Critical Care Department, Hospital Cl\u00ednico San Carlos, Universidad Complutense, Madrid, Spain.",
            "firstname": "Miguel",
            "initials": "M",
            "lastname": "S\u00e1nchez-Garc\u00eda"
        },
        {
            "affiliation": "Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.\nDepartment of Infectious Diseases, University of Barcelona, Hospital Clinic of Barcelona, Barcelona, Spain.\nIDIBAPS, Institut d'Investigacions Biom\u00e8diques Agust\u00ed-Pi Sunyer, Barcelona, Spain.",
            "firstname": "Alex",
            "initials": "A",
            "lastname": "Soriano"
        },
        {
            "affiliation": "Intensive Care Medicine Department, Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain.",
            "firstname": "Maria Cruz",
            "initials": "MC",
            "lastname": "Soriano-Cuesta"
        },
        {
            "affiliation": "Shionogi SLU, Calle de Serrano 45, Madrid, 28001, Spain.",
            "firstname": "A Javier",
            "initials": "AJ",
            "lastname": "Gonzalez Calvo"
        },
        {
            "affiliation": "Shionogi BV, London, UK.",
            "firstname": "Andreas",
            "initials": "A",
            "lastname": "Karas"
        },
        {
            "affiliation": "Shionogi SLU, Calle de Serrano 45, Madrid, 28001, Spain. jessica.sarda@shionogi.eu.",
            "firstname": "Jessica",
            "initials": "J",
            "lastname": "Sarda"
        },
        {
            "affiliation": "Shionogi BV, London, UK.",
            "firstname": "Stefano",
            "initials": "S",
            "lastname": "Verardi"
        },
        {
            "affiliation": "Intensive Care Department, SODIR Reseach Group, Vall d'Hebron Institut de Recerca, Hospital Universitari Vall d'Hebr\u00f3n, Universitat Aut\u00f2noma de Barcelona, Barcelona, Spain.",
            "firstname": "Ricard",
            "initials": "R",
            "lastname": "Ferrer"
        }
    ],
    "conclusions": null,
    "copyrights": "\u00a9 2025. The Author(s).",
    "doi": "10.1007/s10096-025-05108-6\n10.1016/S0140-6736(21)02724-0\n10.1186/s12879-017-2383-z\n10.1093/ofid/ofz194\n10.1186/s13054-020-2742-9\n10.1093/jac/dkad262\n10.1016/S1473-3099(17)30753-3\n10.1186/s13613-023-01153-6\n10.1016/j.cmi.2023.12.026\n10.1016/j.ejmech.2018.06.014\n10.1093/cid/ciz826\n10.1093/cid/ciz827\n10.1128/spectrum.02712-21\n10.1089/mdr.2022.0279\n10.1016/j.jgar.2021.06.011\n10.1093/jac/dkad396\n10.1128/spectrum.03836-23\n10.1128/spectrum.04181-23\n10.1093/jacamr/dlab188\n10.1128/aac.00194-23\n10.1093/ofid/ofad329\n10.1128/aac.00405-23\n10.1128/spectrum.03108-23\n10.3389/fmicb.2024.1347521\n10.1128/AAC.02109-13\n10.1186/s13054-015-0926-5\n10.1128/AAC.02400-17\n10.1080/14787210.2022.2020099\n10.1093/cid/ciz816\n10.2147/IDR.S350976\n10.3390/antibiotics11101352\n10.1056/NEJMoa1703058\n10.1128/spectrum.00674-23\n10.37201/req/098.2023\n10.1016/j.cmi.2021.11.025\n10.1186/s13613-023-01155-4\n10.1007/s40121-023-00776-3\n10.3390/microorganisms11040984\n10.3390/antibiotics12040746\n10.1093/jac/dkad298",
    "journal": "European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology",
    "keywords": [
        "Pseudomonas aeruginosa",
        "Carbapenem resistance",
        "Cefiderocol",
        "Early appropriate therapy",
        "Gram-negative",
        "Limited treatment options",
        "Multidrug resistance"
    ],
    "methods": null,
    "publication_date": "2025-03-25",
    "pubmed_id": "40131647\n28415969\n31198817\n32000834\n37606528\n29276051\n37462830\n38160753\n29960205\n31724047\n31724049\n35262394\n37253158\n34274538\n38153232\n38483164\n38904361\n34909691\n37347188\n37496600\n37404159\n38206034\n38414772\n24342638\n25944081\n29378722\n34937518\n31545346\n35241917\n28528569\n37367629\n37882320\n34923128\n37400647\n36943617\n37110408\n37807834",
    "results": "Overall, 261 patients were eligible for analysis. Median (interquartile range) age was 61 (49-68) years, 202 (77.4%) were male and 165 (63.2%) were in the intensive care unit. The most frequent diagnoses were respiratory tract infection (47.9%), intra-abdominal infection (14.6%), and urinary tract infection (14.6%). The median (IQR) duration of cefiderocol treatment was 10 (7-14) days. Overall, the clinical cure rate was 80.5% (210/261) and the 28-day mortality rate was 21.5% (56/261). In patients with Pseudomonas aeruginosa infection (66.7% [n\u2009=\u2009174], including 73 [42%] with metallo-\u03b2-lactamases), the clinical cure rate was 84.5% (147/174) and the 28-day mortality was 17.2% (30/174). Logistic regression analysis showed that prior antibiotic treatment for >\u20097 days (OR 0.19, 95% CI 0.05-0.56) and mechanical ventilation (OR 0.32, 95% CI 0.15-0.67) were independent negative predictive factors for clinical cure. ADRs occurred in seven patients, six events resolved, and one was fatal (toxic epidermal necrolysis).",
    "title": "Effectiveness and safety of cefiderocol treatment in patients with Gram-negative bacterial infections in Spain in the early access programme: results of the PERSEUS study.",
    "xml": "<Element 'PubmedArticle' at 0x788502a7dee0>"
}