RT journal article
T1 How to use novel antimicrobials beyond official indications: an expert consensus
A1 Retamar Gentil, Pilar
A1 Alegre Albendea, María
A1 Valiente de Santis, Lucia
A1 Castón-Osorio, Juan José
A1 Márquez-Gómez, Ignacio
A1 Corzo-Delgado, Juan Enrique
A1 Praena Segovia, Julia
A1 Herrero Rodríguez, Carmen
A1 Esteban Moreno, M. Ángeles
A1 Martín Aspas, Andrés
A1 Jiménez Aguilar, Patricia
A1 Martínez-Marcos, Francisco Javier
A1 López Cardenas, Salvador
A1 Ojeda Burgos, Guillermo
A1 Sadyrbaeva Dolgova, Svetlana
A1 Anguita Santos, Francisco
A1 Rodríguez Baño, Jesús
A1 Palacio Baena, Zaira
A2 Cirugía
A2 Medicina
AB ObjectivesTo establish a regional expert consensus on off-label indications for recently approved antimicrobials, based on a structured Delphi methodology, to support antimicrobial stewardship programs (ASPs) in Andalusia, Spain.MethodsAs part of the NEW_SAFE project, a modified Delphi process was employed involving 32 experts in Infectious Diseases and Intensive Care from 14 Andalusian hospitals. The process comprised three survey rounds evaluating off-label uses of eight drugs: ceftazidime-avibactam, ceftolozane-tazobactam, cefiderocol, ceftaroline, ceftobiprole, dalbavancin, tedizolid, and isavuconazole. Clinical scenarios were assessed under predefined conditions (efficacy/safety, ecological impact, and cost) and circumstances (empirical versus targeted use, resistance prevalence, PK/PD advantage).ResultsThe expert panel reached positive consensus (≥80% agreement) on specific off-label targeted uses for all drugs except ceftobiprole. Empirical use was generally discouraged except under clear PK/PD advantages or resistance profiles without alternatives. Notably, dalbavancin, ceftaroline, and ceftazidime-avibactam received multiple targeted-use endorsements, particularly for endocarditis, osteoarticular infections, and bacteraemia. Isavuconazole was recommended for rare fungal infections and in cases where it offers pharmacological advantages.ConclusionsThis consensus supports the judicious off-label use of new antimicrobials in specific clinical scenarios where therapeutic gaps exist. The guidance prioritizes targeted treatment over empirical use, aligning with international ASP principles and WHO recommendations. These results provide a regional reference to optimize ASP initiatives focus on new antibiotic use while minimizing ecological impact and resistance development.
PB Oxford University Press
SN 2632-1823
YR 2025
FD 2025-11-24
LK http://hdl.handle.net/10498/39551
UL http://hdl.handle.net/10498/39551
LA eng
DS Repositorio Institucional de la Universidad de Cádiz
RD 09-may-2026