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Ceftazidime‐Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups

Clinical and translational science, 2019-03, Vol.12 (2), p.151-163 [Peer Reviewed Journal]

2018 University of Liverpool. published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. ;2018 University of Liverpool. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. ;2019. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;ISSN: 1752-8054 ;EISSN: 1752-8062 ;DOI: 10.1111/cts.12585 ;PMID: 30221827

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Title:
Ceftazidime‐Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups
Author: Li, Jianguo ; Lovern, Mark ; Green, Michelle L. ; Chiu, Joannellyn ; Zhou, Diansong ; Comisar, Craig ; Xiong, Yuan ; Hing, Jeremy ; MacPherson, Merran ; Wright, James G. ; Riccobene, Todd ; Carrothers, Timothy J. ; Das, Shampa
Subjects: Antimicrobial agents ; Bacterial infections ; Ceftazidime ; Clinical trials ; Computer simulation ; Creatinine ; Data dictionaries ; Datasets ; Drug dosages ; Employees ; Exposure ; FDA approval ; Hospitals ; Infections ; Laboratories ; Nosocomial infection ; Pathogens ; Patients ; Pharmacodynamics ; Pharmacokinetics ; Pneumonia ; Renal function ; Stockholders ; Studies ; Target recognition ; Urinary tract ; Ventilators
Is Part Of: Clinical and translational science, 2019-03, Vol.12 (2), p.151-163
Description: Ceftazidime‐avibactam is a novel β‐lactam/β‐lactamase inhibitor combination for the treatment of serious infections caused by resistant gram‐negative pathogens. Population pharmacokinetic (PopPK) models were built to incorporate pharmacokinetic (PK) data from five phase III trials in patients with complicated intra‐abdominal infection (cIAI), complicated urinary tract infection (cUTI), or nosocomial (including ventilator‐associated) pneumonia. Ceftazidime and avibactam pharmacokinetics were well‐described by two‐compartment disposition models, with creatinine clearance (CrCL) the key covariate determining clearance variability. Steady‐state ceftazidime and avibactam exposure for most patient subgroups differed by ≤ 20% vs. healthy volunteers. Probability of PK/pharmacodynamic (PD) target attainment (free plasma ceftazidime > 8 mg/L and avibactam > 1 mg/L for ≥ 50% of dosing interval) was ≥ 94.9% in simulations for all patient subgroups, including indication and renal function categories. No exposure‐microbiological response relationship was identified because target exposures were achieved in almost all patients. These modeling results support the approved ceftazidime‐avibactam dosage regimens (2000‐500 mg every 8 hours, adjusted for CrCL ≤ 50 mL/min).
Publisher: United States: John Wiley & Sons, Inc
Language: English
Identifier: ISSN: 1752-8054
EISSN: 1752-8062
DOI: 10.1111/cts.12585
PMID: 30221827
Source: PubMed Central
Wiley Online Library Open Access
ProQuest Central
DOAJ Directory of Open Access Journals

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Ceftazidime‐Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups

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