dc.creator | Marín Candón, Alicia | es |
dc.creator | Rosso Fernández, Clara María | es |
dc.creator | Bustos de Godoy, Natalia | es |
dc.creator | López Cerero, Lorena | es |
dc.creator | Gutiérrez Gutiérrez, Belén | es |
dc.creator | López Cortés, Luis Eduardo | es |
dc.creator | Merino Bohórquez, Vicente | es |
dc.creator | Retamar Gentil, Pilar | es |
dc.creator | Pascual Hernández, Álvaro | es |
dc.creator | Rodríguez-Baño, Jesús | es |
dc.date.accessioned | 2022-03-08T08:21:39Z | |
dc.date.available | 2022-03-08T08:21:39Z | |
dc.date.issued | 2021 | |
dc.identifier.citation | Marín Candón, A., Rosso Fernández, C.M., Bustos de Godoy, N., López Cerero, L., Gutiérrez Gutiérrez, B., López Cortés, L.E.,...,Rodríguez-Baño, J. (2021). Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTÉ): protocol for a randomised, pragmatic trial. BMJ Open, 11 (9), e049481. | |
dc.identifier.issn | 2044-6055 | es |
dc.identifier.uri | https://hdl.handle.net/11441/130507 | |
dc.description.abstract | Introduction: Alternatives to carbapenems are needed in the treatment of third-generation cephalosporin-resistant Enterobacterales (3GCR-E). Temocillin is a suitable candidate, but comparative randomised studies are lacking. The objective is to investigate if temocillin is non-inferior to carbapenems in the targeted treatment of bacteraemia due to 3GCR-E.
Methods and analysis: Multicentre, open-label, randomised, controlled, pragmatic phase 3 trial. Patients with bacteraemia due to 3GCR-E will be randomised to receive intravenously temocillin (2 g three times a day) or carbapenem (meropenem 1 g three times a day or ertapenem 1 g once daily). The primary endpoint will be clinical success 7–10 days after end of treatment with no recurrence or death at day 28. Adverse events will be collected; serum levels of temocillin will be investigated in a subset of patients. For a 10% non-inferiority margin, 334 patients will be included (167 in each study arm). For the primary analysis, the absolute difference with one-sided 95% CI in the proportion of patients reaching the primary endpoint will be compared in the modified intention-to-treat population.
Ethics and dissemination: The study started after approval of the Spanish Regulatory Agency and the reference institutional review board. Data will be published in peer-reviewed journals.
Trial registration number: NCT04478721. | es |
dc.description.sponsorship | Instituto de Salud Carlos III ICI19/00093 | es |
dc.description.sponsorship | Ministerio de Economía, Industria y Competitividad y Fondos FEDER RD16/0016/0001, 0002, 0004, 0008, 0009, 0010, 0011, 0013, 0015 | es |
dc.format | application/pdf | es |
dc.format.extent | 8 p. | es |
dc.language.iso | eng | es |
dc.publisher | BMJ Publishing Group | es |
dc.relation.ispartof | BMJ Open, 11 (9), e049481. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.title | Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTÉ): protocol for a randomised, pragmatic trial | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Farmacología | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Microbiología | es |
dc.relation.projectID | ICI19/00093 | es |
dc.relation.projectID | RD16/0016/0001 | es |
dc.relation.projectID | RD16/0016/0002 | es |
dc.relation.projectID | RD16/0016/0004 | es |
dc.relation.projectID | RD16/0016/0008 | es |
dc.relation.projectID | RD16/0016/0009 | es |
dc.relation.projectID | RD16/0016/0010 | es |
dc.relation.projectID | RD16/0016/0011 | es |
dc.relation.projectID | RD16/0016/0013 | es |
dc.relation.projectID | RD16/0016/0015 | es |
dc.relation.publisherversion | http://dx.doi.org/10.1136/bmjopen-2021-049481 | es |
dc.identifier.doi | 10.1136/bmjopen-2021-049481 | es |
dc.journaltitle | BMJ Open | es |
dc.publication.volumen | 11 | es |
dc.publication.issue | 9 | es |
dc.publication.initialPage | e049481 | es |
dc.contributor.funder | Instituto de Salud Carlos III | es |
dc.contributor.funder | Ministerio de Economia, Industria y Competitividad (MINECO). España | es |
dc.contributor.funder | European Commission (EC). Fondo Europeo de Desarrollo Regional (FEDER) | es |