Article
Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTÉ): protocol for a randomised, pragmatic trial
Author/s | 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 ![]() ![]() ![]() ![]() ![]() ![]() ![]() |
Department | Universidad de Sevilla. Departamento de Farmacología Universidad de Sevilla. Departamento de Medicina Universidad de Sevilla. Departamento de Microbiología |
Date | 2021 |
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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. ... 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. |
Funding agencies | Instituto de Salud Carlos III Ministerio de Economia, Industria y Competitividad (MINECO). España European Commission (EC). Fondo Europeo de Desarrollo Regional (FEDER) |
Project ID. | ICI19/00093
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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. |
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10.1136_bmjopen-2021-049481.pdf | 297.9Kb | ![]() | View/ | |