Artículo
Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTÉ): protocol for a randomised, pragmatic trial
Autor/es | Marín Candón, Alicia
Rosso Fernández, Clara María Bustos de Godoy, Natalia López Cerero, Lorena Gutiérrez Gutiérrez, Belén López Cortés, Luis Eduardo Merino Bohórquez, Vicente Retamar Gentil, Pilar Pascual Hernández, Álvaro Rodríguez-Baño, Jesús |
Departamento | Universidad de Sevilla. Departamento de Farmacología Universidad de Sevilla. Departamento de Medicina Universidad de Sevilla. Departamento de Microbiología |
Fecha de publicación | 2021 |
Fecha de depósito | 2022-03-08 |
Publicado en |
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Resumen | 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. ... 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. |
Agencias financiadoras | Instituto de Salud Carlos III Ministerio de Economia, Industria y Competitividad (MINECO). España European Commission (EC). Fondo Europeo de Desarrollo Regional (FEDER) |
Identificador del proyecto | ICI19/00093
RD16/0016/0001 RD16/0016/0002 RD16/0016/0004 RD16/0016/0008 RD16/0016/0009 RD16/0016/0010 RD16/0016/0011 RD16/0016/0013 RD16/0016/0015 |
Cita | 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. |
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10.1136_bmjopen-2021-049481.pdf | 297.9Kb | [PDF] | Ver/ | |