a 2024

Current Research in Colistin Therapeutic Drug Monitoring – Pre-eliminary Results of Investigator-Initiated Clinical Trial COL-ECMO2022

RYCHLÍČKOVÁ, Jitka a Pavel SUK

Základní údaje

Originální název

Current Research in Colistin Therapeutic Drug Monitoring – Pre-eliminary Results of Investigator-Initiated Clinical Trial COL-ECMO2022

Název česky

Current Research in Colistin Therapeutic Drug Monitoring – Pre-eliminary Results of Investigator-Initiated Clinical Trial COL-ECMO2022

Vydání

CZECRIN Annual Research Conference and CONSCIOUS II multiplier event, 2024

Další údaje

Jazyk

angličtina

Typ výsledku

Konferenční abstrakt

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Česká republika

Utajení

není předmětem státního či obchodního tajemství

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/24:00138115

Organizační jednotka

Lékařská fakulta

ISBN

978-80-280-0588-7

Klíčová slova anglicky

colistin; therapeutic drug monitoring; pharmacokinetics; nvestigator-initiated clinical trial
Změněno: 17. 1. 2025 09:27, Mgr. Tereza Miškechová

Anotace

V originále

Recap the shortcomings in colistin therapeutic drug monitoring (TDM) and summarize lessons learned from several follow-up projects that address these gaps. A literature review on colistin TDM. Development of a method for determining colistin/CMS in three matrices. Short-term stability tests of colistin and CMS in the above matrices. Preliminary results of a prospective, non-randomized, single-center phase IV pharmacokinetic clinical trial to assess the effect of ECMO on the pharmacokinetics of colistin and CMS (COL-ECMO2022 trial). The primary shortcomings in colistin TDM are the lack of a method for routine measurement, insufficient stability data for samples, a limited availability of the population pharmacokinetic models. A simple LC-MS/MS method for the determination of both substrates has been established and validated in the associated laboratory; it is currently the only facility in the Czech Republic capable of determining colistin and CMS in plasma/serum. The total analysis time is 5 minutes. Short-term stability data confirming a relationship between colistin/CMS stability and temperature/temperature and concentration provide valuable input for preanalytical sample processing. 23 Preliminary results of the pharmacokinetic study show a high colistin exposure despite standard dosage use. Colistin AUCSS,24h was 165±128 mg.h/L, cSS corresponds to 6.9±5.3 mg/L. Considering the variable relationship between CMS concentration and achieved colistin concentrations, the determination of colistin itself, especially trough concentration, seems to be crucial; the determination of CMS is not essential. Real-time TDM appears to be a fundamental condition for the rational use of colistin, and the above data helps with practical implementation.

Návaznosti

LM2023049, projekt VaV
Název: Český národní uzel Evropské sítě infrastruktur klinického výzkumu
Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, CZECRIN - Czech National Node to the European Clinical Research Infrastructure Network