European Journal of Clinical Microbiology & Infectious Diseases
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Published By Springer-Verlag

1435-4373, 0934-9723

Eric P. Skaar ◽  
Roger Echols ◽  
Yuko Matsunaga ◽  
Anju Menon ◽  
Simon Portsmouth

AbstractCritically ill patients often present with low serum iron levels or anemia. We evaluated the impact of iron levels and iron homeostasis on the efficacy and safety of cefiderocol, an iron-chelator siderophore cephalosporin, in patients with nosocomial pneumonia in a post hoc analysis of the randomized, double-blind, Phase 3 APEKS-NP study (NCT03032380). Patients with Gram-negative nosocomial pneumonia received cefiderocol 2 g, 3-h infusion, q8h, or high-dose, extended-infusion meropenem 2 g, 3-h infusion, q8h, for 7–14 days. Efficacy and safety parameters, including specific iron homeostasis parameters (i.e., hepcidin, iron, total iron binding capacity, transferrin saturation), were analyzed according to baseline iron levels. In the cefiderocol and meropenem arms, 79.1% (117/148) and 83.3% (125/150) randomized patients, respectively, had low baseline serum iron levels. Rates of 14-day (12.3% [14/114] vs 11.6% [14/121]) and 28-day all-cause mortality (20.5% [23/112] vs 19.0% [23/121]), clinical cure (63.2% [72/114] vs 67.2% [82/122]), and microbiological eradication (43.6% [41/94] vs 48.1% [51/106]) at test of cure were similar in cefiderocol vs meropenem arms, respectively. In the overall safety population, rates of anemia-related adverse events were similar (cefiderocol arm 18.2% [27/148], meropenem arm 18.7% [28/150]). Changes from baseline to test of cure in hepcidin, iron, total iron binding capacity, and transferrin saturation were similar between treatment arms. Cefiderocol treatment did not affect iron homeostasis, and its efficacy and safety were not influenced by baseline serum iron levels. registration: NCT03032380. Date of registration: 26 January 2017.

Rona Grossman ◽  
Amos Adler ◽  
Mor Rubinstein ◽  
Israel Nissan ◽  
Hasia Kaidar-Shwartz ◽  

Christine Katlama ◽  
Yasmine Dudoit ◽  
Julien Huyard ◽  
Christine Blanc ◽  
Cathia Soulié ◽  

Annette C. Westgeest ◽  
Emile F. Schippers ◽  
Nathalie M. Delfos ◽  
Leo G. Visser ◽  
Johan W. de Fijter ◽  

Gabriele Arcari ◽  
Alessandra Oliva ◽  
Federica Sacco ◽  
Federica Maria Di Lella ◽  
Giammarco Raponi ◽  

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