ArticleJAC-antimicrobial resistance2025
How to use novel antimicrobials beyond official indications: an expert consensus.
Article in JAC-antimicrobial resistance, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Efficay of cefiderocol as salvage therapy in tricuspid endocarditis due to multidrug-resistantRevista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026Article
- ASP-COMPLEX: redefining antimicrobial stewardship to improve outcomes in high-risk patients with severe infections.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026Review
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objectives: To 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. Methods: As 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). Results: The 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. Conclusions: This 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.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.