Marín Candón, AliciaRosso Fernández, Clara MaríaBustos de Godoy, NataliaLópez Cerero, LorenaGutiérrez Gutiérrez, BelénLópez-Cortés, Luis E.León León, María JoséMerino Bohórquez, VicenteRetamar Gentil, PilarPascual Hernández, ÁlvaroRodríguez-Baño, Jesús2022-03-082022-03-082021Marín Candón, A., Rosso Fernández, C.M., Bustos de Godoy, N., López Cerero, L., Gutiérrez Gutiérrez, B., López-Cortes, 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. https://doi.org/10.1136/bmjopen-2021-049481.2044-6055https://hdl.handle.net/11441/130507Introduction: 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.application/pdf8 p.engAttribution-NonCommercial-NoDerivatives 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccesshttps://doi.org/10.1136/bmjopen-2021-049481