Studie COLECMO2022: předběžné výsledky
| Title in English | COLECMO2022 study: preliminary results |
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| Authors | |
| Year of publication | 2024 |
| Type | Conference abstract |
| MU Faculty or unit | |
| Citation | |
| Description | Introduction: Colistin is one of the antibiotics with an exposition-dependent effect. Achieving the therapeutic target (Css approximately 2 mg/L) is complicated by the interindividually variable and generally complex pharmacokinetics of colistin. At the same time, colistin is an antibiotic with a narrow therapeutic window, with nephrotoxicity being the limiting factor. The transferability of pharmacokinetic data between products from different manufacturers is also problematic. Methods: Preliminary results of a prospective, non-randomized, Phase IV pharmacokinetic clinical trial to evaluate the effect of ECMO on the pharmacokinetics of colistin and CMS (COL-ECMO2022, EudraCT 2022-000291-19, ClinicalTrials.gov ID NCT05542446). This is an investigator-initiated, single-center clinical trial conducted in the Czech Republic. All data will be presented as mean ± standard deviation.Results: 7 patients (6 males, aged 49±24 years, body weight 94±27 kg, height 175±5 cm, creatinine clearance 1.99±1.59 ml/s/1.73 m2) were included in the preliminary analysis. The steady-state concentrations (Css) of colistin in this cohort were 6.9±5.3 mg/l. Thus, colistin exposure was generally high despite the use of standard dosing for critically ill patients. The results confirm the rationality of using a loading dose and provide support for the frequency of sampling for TDM of colistin. Simultaneous determination of prodrug concentrations based on these results does not provide a more precise estimate of colistin concentrations. CONCLUSION: Preliminary pharmacokinetic data from the COL-ECMO2022 study show higher exposure to colistin despite its standard dosing. TDM is necessary to ensure the safety as well as the efficacy of colistin therapy. Supported by the state budget through the Ministry of Education and Science through the VVI CZECRIN project (LM2023049). |
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