Marín-Candón, AliciaRosso-Fernández, Clara MBustos de Godoy, NataliaLópez-Cerero, LorenaGutiérrez-Gutiérrez, BelénLópez-Cortés, Luis EduardoBarrera Pulido, LydiaBorreguero Borreguero, IreneLeón, María JoséMerino, VicenteCamean-Fernández, ManuelRetamar, PilarSalamanca, ElenaPascual, AlvaroRodriguez-Baño, JesúsASTARTÉ Study Group2025-01-072025-01-072021-09-27https://hdl.handle.net/10668/27611Alternatives 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. 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. The study started after approval of the Spanish Regulatory Agency and the reference institutional review board. Data will be published in peer-reviewed journals. NCT04478721.enAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/bacteriologyclinical pharmacologyinfection controlinfectious diseasesmicrobiologyBacteremiaCephalosporinsClinical Trials, Phase III as TopicEnterobacteriaceaeHumansMeropenemMulticenter Studies as TopicPenicillinsPragmatic Clinical Trials as TopicRandomized Controlled Trials as Topicresearch article34580096open access10.1136/bmjopen-2021-0494812044-6055PMC8477313https://bmjopen.bmj.com/content/bmjopen/11/9/e049481.full.pdfhttps://pmc.ncbi.nlm.nih.gov/articles/PMC8477313/pdf