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http://repo.knmu.edu.ua/handle/123456789/32485
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DC Field | Value | Language |
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dc.contributor.author | Makieieva, Nataliia | - |
dc.contributor.author | Tøndel, Camilla | - |
dc.contributor.author | Bradley, John S. | - |
dc.contributor.author | Roilides, Emmanuel | - |
dc.contributor.author | Matthew, S. Kelly | - |
dc.contributor.author | Patel, Munjal | - |
dc.contributor.author | Vaddady, Pavan | - |
dc.contributor.author | Maniar, Alok | - |
dc.contributor.author | Paschke, Amanda | - |
dc.contributor.author | Chen, Luke F. | - |
dc.date.accessioned | 2023-09-13T08:59:22Z | - |
dc.date.available | 2023-09-13T08:59:22Z | - |
dc.date.issued | 2023 | - |
dc.identifier.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. | en_US |
dc.identifier.uri | http://repo.knmu.edu.ua/handle/123456789/32485 | - |
dc.description.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. | en_US |
dc.language.iso | en | en_US |
dc.subject | carbapenem/β-lactamase inhibitor | en_US |
dc.subject | children | en_US |
dc.subject | dose selection | en_US |
dc.subject | gram-negative bacterial infection | en_US |
dc.subject | imipenem | en_US |
dc.subject | cilastatin | en_US |
dc.subject | relebactam | en_US |
dc.subject | 2023а | en_US |
dc.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 | en_US |
dc.type | Article | en_US |
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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