Cargando…

Assessment of Antibiotic Pharmacokinetics, Molecular Biomarkers and Clinical Status in Critically Ill Adults Diagnosed with Community-Acquired Pneumonia and Receiving Intravenous Piperacillin/Tazobactam and Hydrocortisone over the First Five Days of Intensive Care: An Observational Study (STROBE Compliant)

Severe community-acquired pneumonia (CAP) is a condition that frequently requires intensive care and, eventually, can cause to death. Piperacillin/tazobactam antibiotic therapy is employed as an empiric intravenous regimen, in many cases supplemented with intravenous bolus hydrocortisone treatment....

Descripción completa

Detalles Bibliográficos
Autores principales: Vincze, István, Czermann, Rita, Nagy, Zsuzsanna, Kovács, Mária, Neely, Michael, Farkas, Róbert, Kocsis, Ibolya, Karvaly, Gellért Balázs, Kopitkó, Csaba
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9324075/
https://www.ncbi.nlm.nih.gov/pubmed/35887904
http://dx.doi.org/10.3390/jcm11144140
_version_ 1784756718172897280
author Vincze, István
Czermann, Rita
Nagy, Zsuzsanna
Kovács, Mária
Neely, Michael
Farkas, Róbert
Kocsis, Ibolya
Karvaly, Gellért Balázs
Kopitkó, Csaba
author_facet Vincze, István
Czermann, Rita
Nagy, Zsuzsanna
Kovács, Mária
Neely, Michael
Farkas, Róbert
Kocsis, Ibolya
Karvaly, Gellért Balázs
Kopitkó, Csaba
author_sort Vincze, István
collection PubMed
description Severe community-acquired pneumonia (CAP) is a condition that frequently requires intensive care and, eventually, can cause to death. Piperacillin/tazobactam antibiotic therapy is employed as an empiric intravenous regimen, in many cases supplemented with intravenous bolus hydrocortisone treatment. The individual and condition-dependent pharmacokinetic properties of these drugs may lead to therapeutic failure. The impact of systemic inflammation, as well as of hydrocortisone on the altered pharmacokinetics of piperacillin is largely unknown. The protocol of a clinical study aimed at the characterization of the pharmacokinetics of piperacillin and tazobactam and its association with the concentrations of inflammatory markers and adrenal steroids during CAP therapy will be investigated in up to 40 critically ill patients. The serum concentrations of piperacillin and tazobactam, cortisol, cortisone, corticosterone and 11-deoxycortisol and interleukin-6 levels, as well as routine clinical chemistry and hematology parameters will be monitored from the beginning of treatment for up to five days. Nonparametric population pharmacokinetic modeling and Monte-Carlo simulations will be performed to make estimates of the pharmacokinetics of piperacillin and tazobactam and the probability of pharmacokinetic-pharmacodynamic target attainment. The observed individual characteristics and changes will be correlated with clinical and laboratory findings. The protocol of the observational study will be designed following the STROBE guideline.
format Online
Article
Text
id pubmed-9324075
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-93240752022-07-27 Assessment of Antibiotic Pharmacokinetics, Molecular Biomarkers and Clinical Status in Critically Ill Adults Diagnosed with Community-Acquired Pneumonia and Receiving Intravenous Piperacillin/Tazobactam and Hydrocortisone over the First Five Days of Intensive Care: An Observational Study (STROBE Compliant) Vincze, István Czermann, Rita Nagy, Zsuzsanna Kovács, Mária Neely, Michael Farkas, Róbert Kocsis, Ibolya Karvaly, Gellért Balázs Kopitkó, Csaba J Clin Med Protocol Severe community-acquired pneumonia (CAP) is a condition that frequently requires intensive care and, eventually, can cause to death. Piperacillin/tazobactam antibiotic therapy is employed as an empiric intravenous regimen, in many cases supplemented with intravenous bolus hydrocortisone treatment. The individual and condition-dependent pharmacokinetic properties of these drugs may lead to therapeutic failure. The impact of systemic inflammation, as well as of hydrocortisone on the altered pharmacokinetics of piperacillin is largely unknown. The protocol of a clinical study aimed at the characterization of the pharmacokinetics of piperacillin and tazobactam and its association with the concentrations of inflammatory markers and adrenal steroids during CAP therapy will be investigated in up to 40 critically ill patients. The serum concentrations of piperacillin and tazobactam, cortisol, cortisone, corticosterone and 11-deoxycortisol and interleukin-6 levels, as well as routine clinical chemistry and hematology parameters will be monitored from the beginning of treatment for up to five days. Nonparametric population pharmacokinetic modeling and Monte-Carlo simulations will be performed to make estimates of the pharmacokinetics of piperacillin and tazobactam and the probability of pharmacokinetic-pharmacodynamic target attainment. The observed individual characteristics and changes will be correlated with clinical and laboratory findings. The protocol of the observational study will be designed following the STROBE guideline. MDPI 2022-07-16 /pmc/articles/PMC9324075/ /pubmed/35887904 http://dx.doi.org/10.3390/jcm11144140 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Protocol
Vincze, István
Czermann, Rita
Nagy, Zsuzsanna
Kovács, Mária
Neely, Michael
Farkas, Róbert
Kocsis, Ibolya
Karvaly, Gellért Balázs
Kopitkó, Csaba
Assessment of Antibiotic Pharmacokinetics, Molecular Biomarkers and Clinical Status in Critically Ill Adults Diagnosed with Community-Acquired Pneumonia and Receiving Intravenous Piperacillin/Tazobactam and Hydrocortisone over the First Five Days of Intensive Care: An Observational Study (STROBE Compliant)
title Assessment of Antibiotic Pharmacokinetics, Molecular Biomarkers and Clinical Status in Critically Ill Adults Diagnosed with Community-Acquired Pneumonia and Receiving Intravenous Piperacillin/Tazobactam and Hydrocortisone over the First Five Days of Intensive Care: An Observational Study (STROBE Compliant)
title_full Assessment of Antibiotic Pharmacokinetics, Molecular Biomarkers and Clinical Status in Critically Ill Adults Diagnosed with Community-Acquired Pneumonia and Receiving Intravenous Piperacillin/Tazobactam and Hydrocortisone over the First Five Days of Intensive Care: An Observational Study (STROBE Compliant)
title_fullStr Assessment of Antibiotic Pharmacokinetics, Molecular Biomarkers and Clinical Status in Critically Ill Adults Diagnosed with Community-Acquired Pneumonia and Receiving Intravenous Piperacillin/Tazobactam and Hydrocortisone over the First Five Days of Intensive Care: An Observational Study (STROBE Compliant)
title_full_unstemmed Assessment of Antibiotic Pharmacokinetics, Molecular Biomarkers and Clinical Status in Critically Ill Adults Diagnosed with Community-Acquired Pneumonia and Receiving Intravenous Piperacillin/Tazobactam and Hydrocortisone over the First Five Days of Intensive Care: An Observational Study (STROBE Compliant)
title_short Assessment of Antibiotic Pharmacokinetics, Molecular Biomarkers and Clinical Status in Critically Ill Adults Diagnosed with Community-Acquired Pneumonia and Receiving Intravenous Piperacillin/Tazobactam and Hydrocortisone over the First Five Days of Intensive Care: An Observational Study (STROBE Compliant)
title_sort assessment of antibiotic pharmacokinetics, molecular biomarkers and clinical status in critically ill adults diagnosed with community-acquired pneumonia and receiving intravenous piperacillin/tazobactam and hydrocortisone over the first five days of intensive care: an observational study (strobe compliant)
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9324075/
https://www.ncbi.nlm.nih.gov/pubmed/35887904
http://dx.doi.org/10.3390/jcm11144140
work_keys_str_mv AT vinczeistvan assessmentofantibioticpharmacokineticsmolecularbiomarkersandclinicalstatusincriticallyilladultsdiagnosedwithcommunityacquiredpneumoniaandreceivingintravenouspiperacillintazobactamandhydrocortisoneoverthefirstfivedaysofintensivecareanobservationalstudystro
AT czermannrita assessmentofantibioticpharmacokineticsmolecularbiomarkersandclinicalstatusincriticallyilladultsdiagnosedwithcommunityacquiredpneumoniaandreceivingintravenouspiperacillintazobactamandhydrocortisoneoverthefirstfivedaysofintensivecareanobservationalstudystro
AT nagyzsuzsanna assessmentofantibioticpharmacokineticsmolecularbiomarkersandclinicalstatusincriticallyilladultsdiagnosedwithcommunityacquiredpneumoniaandreceivingintravenouspiperacillintazobactamandhydrocortisoneoverthefirstfivedaysofintensivecareanobservationalstudystro
AT kovacsmaria assessmentofantibioticpharmacokineticsmolecularbiomarkersandclinicalstatusincriticallyilladultsdiagnosedwithcommunityacquiredpneumoniaandreceivingintravenouspiperacillintazobactamandhydrocortisoneoverthefirstfivedaysofintensivecareanobservationalstudystro
AT neelymichael assessmentofantibioticpharmacokineticsmolecularbiomarkersandclinicalstatusincriticallyilladultsdiagnosedwithcommunityacquiredpneumoniaandreceivingintravenouspiperacillintazobactamandhydrocortisoneoverthefirstfivedaysofintensivecareanobservationalstudystro
AT farkasrobert assessmentofantibioticpharmacokineticsmolecularbiomarkersandclinicalstatusincriticallyilladultsdiagnosedwithcommunityacquiredpneumoniaandreceivingintravenouspiperacillintazobactamandhydrocortisoneoverthefirstfivedaysofintensivecareanobservationalstudystro
AT kocsisibolya assessmentofantibioticpharmacokineticsmolecularbiomarkersandclinicalstatusincriticallyilladultsdiagnosedwithcommunityacquiredpneumoniaandreceivingintravenouspiperacillintazobactamandhydrocortisoneoverthefirstfivedaysofintensivecareanobservationalstudystro
AT karvalygellertbalazs assessmentofantibioticpharmacokineticsmolecularbiomarkersandclinicalstatusincriticallyilladultsdiagnosedwithcommunityacquiredpneumoniaandreceivingintravenouspiperacillintazobactamandhydrocortisoneoverthefirstfivedaysofintensivecareanobservationalstudystro
AT kopitkocsaba assessmentofantibioticpharmacokineticsmolecularbiomarkersandclinicalstatusincriticallyilladultsdiagnosedwithcommunityacquiredpneumoniaandreceivingintravenouspiperacillintazobactamandhydrocortisoneoverthefirstfivedaysofintensivecareanobservationalstudystro