Please use this identifier to cite or link to this item:
http://repo.knmu.edu.ua/handle/123456789/32485
Title: | Pharmacokinetics, Safety, and Tolerability of Imipenem / Cilastatin/Relebactam in Children with Confirmed or Suspected Gram-Negative Bacterial Infections: A Phase 1b, Open-Label, Single-Dose Clinical Trial |
Authors: | Makieieva, Nataliia Tøndel, Camilla Bradley, John S. Roilides, Emmanuel Matthew, S. Kelly Patel, Munjal Vaddady, Pavan Maniar, Alok Paschke, Amanda Chen, Luke F. |
Keywords: | carbapenem/β-lactamase inhibitor children dose selection gram-negative bacterial infection imipenem cilastatin relebactam 2023а |
Issue Date: | 2023 |
Citation: | Pharmacokinetics, Safety, and Tolerability of Imipenem / Cilastatin/Relebactam in Children with Confirmed or Suspected Gram-Negative Bacterial Infections: A Phase 1b, Open-Label, Single-Dose Clinical Trial / J. S. Bradley, N. Makieieva, C. Tøndel, E. Roilides, M. S. Kelly, M. Patel, P. Vaddady, A. Maniar, Yi. Zhang, A. Paschke, L. F. Chen // The Journal of Clinical Pharmacology. – 2023. – Vol 0, No 0. – Р. 1–11. – DOI: 10.1002/jcph.2334. |
Abstract: | Imipenem/cilastatin/relebactam is approved for the treatment of serious gram-negative bacterial infections in adults. This study assessed the pharmacokinetics (PK), safety, and tolerability of a single dose of imipenem/cilastatin/relebactam (with a fixed 2:1 ratio of imipenem/cilastatin to relebactam, and with a maximum dose of 15 mg/kg imipenem and 15 mg/kg cilastatin [≤500 mg imipenem and ≤500 mg cilastatin] and 7.5 mg/kg relebactam [≤250 mg relebactam]) in children with confirmed/suspected gram-negative bacterial infections receiving standard-of-care antibacterial therapy. In this phase 1, noncomparative study (ClinicalTrials.gov identifier, NCT03230916), PK parameters from 46 children were analyzed using both population modeling and noncompartmental analysis. The PK/pharmacodynamic (PD) target for imipenem was percent time of the dosing interval that unbound plasma concentration exceeded the minimum inhibitory concentration (%ft>MIC) of ≥30% (MIC = 2 μg/mL). Imipenem and relebactam exceeded plasma PK/PD targets; single doses of imipenem/cilastatin/relebactam were well tolerated with no significant safety concerns identified. These results informed imipenem/cilastatin/relebactam dose selection for further pediatric clinical evaluation. |
URI: | http://repo.knmu.edu.ua/handle/123456789/32485 |
Appears in Collections: | Наукові праці. Кафедра педіатрії № 2 |
Files in This Item:
File | Description | Size | Format | |
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Makieieva_Pharmacokinetics, Safety.pdf | 1,15 MB | Adobe PDF | View/Open |
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