This narrative review critically appraised evidence from phase 2 and 3 RCTs and real-world observational studies on cefiderocol — a siderophore cephalosporin — for treating multidrug-resistant Gram-negative bacterial (MDR-GNB) infections, covering clinical effectiveness, safety, and optimal place-in-therapy across infection sites and pathogens.
RCTs showed cefiderocol was non-inferior to standard-of-care for complicated UTIs, nosocomial pneumonia, and bloodstream infections, but mortality imbalances emerged in *Acinetobacter baumannii* and MBL-producing pathogen subgroups. Real-world data showed more consistent benefit for *Pseudomonas aeruginosa* and carbapenem-resistant Enterobacterales; outcomes for carbapenem-resistant *A. baumannii* remained variable. No clear advantage of combination therapy over monotherapy was established.
- Narrative (not systematic) review design limits reproducibility and introduces selection bias. - Real-world studies are observational, heterogeneous, and prone to confounding. - No pathogen- or infection-specific RCTs available for key subgroups (e.g., carbapenem-resistant *A. baumannii*, MBL producers).
Use cefiderocol early for MDR-GNB infections — especially carbapenem-resistant Enterobacterales and *P. aeruginosa* — within an antimicrobial stewardship framework, but exercise caution in carbapenem-resistant *A. baumannii* and MBL-producing infections where evidence is less consistent. Combination therapy currently offers no proven advantage over monotherapy.
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