ArticleAdvances in therapy2025
Pharmacokinetic, Pharmacokinetic/Pharmacodynamic, and Safety Investigations of Cefiderocol in Chinese Healthy Subjects.
Article in Advances in therapy, 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.
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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.
- EnvZ/OmpR-driven cooperative behavior promotes cefiderocol resistance in a hanging-droplet evolution system.Science advances · 2026Article
- Cefiderocol: A Comprehensive Review of Chemistry, Mechanisms of Resistance, and Clinical Applications in the Era of Multidrug Resistance.Current microbiology · 2025Review
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWe aim to evaluate the safety and pharmacokinetic (PK) properties of cefiderocol in Chinese participants, following single and subsequent multiple administrations of 2 g q8h with 3-h intravenous infusion, and to predict its efficacy for the treatment of Gram-negative bacilli (GNB) infection based on PK/pharmacodynamic (PD) analysis.
methodsThis was an open-label, single-center, single- and multiple-dose phase I study, conducted from September 2022 to October 2022, with 12 eligible healthy Chinese adults (6 men and 6 women). The PK profiles were described by noncompartmental analysis and a two-compartment model using WinNonlin (v.8.1). Monte Carlo simulations (MCS) were performed by R (v.4.3.1) to obtain the probability of target attainment (PTA) as well as the cumulative fraction of response (CFR), based on the previously published data of susceptibility studies for cefiderocol in China.
resultsBoth single and multiple doses of 2 g cefiderocol were well tolerated in healthy Chinese subjects, and no severe treatment-emergent adverse events occurred. The maximum plasma concentration of cefiderocol was observed approximately 3 h after administration and the half-life was about 2.6 h, with no accumulation after multiple dosing. It is worth noting that, the PK profiles, including CL, V1, C
conclusionsCefiderocol is well tolerated by Chinese healthy participants at the dosage regimen of 2 g cefiderocol q8h via 3-h infusion, which is expected to achieve satisfactory efficacy in treating GNB infections in China, although further data for model optimization might still be required. To our knowledge, this is the first study to describe the PK properties of cefiderocol in Chinese subjects, and to predict its microbiological efficacy for treating GNB infection in China.
trial registrationChiCTR2300076607.
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