RT Journal Article
T1 Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTÉ): protocol for a randomised, pragmatic trial.
A1 Marín-Candón, Alicia
A1 Rosso-Fernández, Clara M
A1 Bustos de Godoy, Natalia
A1 López-Cerero, Lorena
A1 Gutiérrez-Gutiérrez, Belén
A1 López-Cortés, Luis Eduardo
A1 Barrera Pulido, Lydia
A1 Borreguero Borreguero, Irene
A1 León, María José
A1 Merino, Vicente
A1 Camean-Fernández, Manuel
A1 Retamar, Pilar
A1 Salamanca, Elena
A1 Pascual, Alvaro
A1 Rodriguez-Baño, Jesús
A1 ASTARTÉ Study Group, 
K1 bacteriology
K1 clinical pharmacology
K1 infection control
K1 infectious diseases
K1 microbiology
AB 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. 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.
YR 2021
FD 2021-09-27
LK https://hdl.handle.net/10668/27611
UL https://hdl.handle.net/10668/27611
LA en
DS RISalud
RD Apr 6, 2025