Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins

Summary

A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant Enterobacteriaceae. The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.

Timeline

Start

2020-12-15

Primary completion

2024-12-26

Completion

2024-12-26

Publications

• Dezza FC, Pulido LB, Borreguero IB, Perez FD, Jimenez VP, de la Rosa Riestra S, Bravo-Ferrer JM, Palacios-Baena ZR, Zuniga MAL, Cobo F, Gomez-Junyent J, Horcajada JP, Merino E, Parra M, Lopez-Contreras J, Rivera A, Regueiro DS, Garcia MP, Cardenas SL, Sanchez MCG, Camacho IP, Ramos SMM, Jimenez EL, Garcia AIA, Perez-Rodriguez MT, Sousa A, Ruiz MS, de Las Revillas Almajano FA, Perez LG, Agirre JG, Cano A, Martinez-Marcos FJ, Pais MJG, Sanchez RE, de la Villa S, Ara JRY, Esteban-Moreno MA, Ruiz-Sancho A, Aragon MP, Fernandez JA, Blandino AMB, Vilchez-Rueda HH, Alvarez-Marin R, Palacios AR, Vazquez EG, Alvarez EN, Rosso-Fernandez C, Gutierrez-Gutierrez B, Pascual A, Lopez-Cerero L, Rodriguez-Bano J; ASTARTE-GEIRAS study group. Temocillin versus carbapenems for bacteraemia due to third-generation cephalosporin-resistant Enterobacterales in Spain (ASTARTE): a multicentre, phase 3, open-label, non-inferiority, randomised clinical trial. Lancet. 2026 Jul 9:S0140-6736(26)00760-9. doi: 10.1016/S0140-6736(26)00760-9. Online ahead of print.
• Marin-Candon A, Rosso-Fernandez CM, Bustos de Godoy N, Lopez-Cerero L, Gutierrez-Gutierrez B, Lopez-Cortes LE, Barrera Pulido L, Borreguero Borreguero I, Leon MJ, Merino V, Camean-Fernandez M, Retamar P, Salamanca E, Pascual A, Rodriguez-Bano J; ASTARTE Study Group. Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTE): protocol for a randomised, pragmatic trial. BMJ Open. 2021 Sep 27;11(9):e049481. doi: 10.1136/bmjopen-2021-049481.

Drugs

Indications