The current study is a pilot study to assess the feasibility of a superordinate project. The final objective of this superordinate project is to describe and model the pharmacokinetic behaviour of a small number of standard antimicrobials used in the treatment of frequent blood stream infections, and to link this via pharmacodynamic models to (inhibition of) bacterial or fungal growth as well as to clinical outcomes in patients.
Patients with a high probability of a blood stream infection and an indication for antimicrobial treatment will be included. The study comprises the identification of patients as potential study participants, obtaining informed consent, documentation of available potential covariates from patient file, withdrawal of pre-study blood samples (PK, PD, microbiology) including documentation of exact time of sampling and processing of the samples, first drug administration including exact documentation (as part of patient care; not as a study intervention), withdrawal of subsequent blood samples (PK, PD, microbiology) during the next 3 days including documentation of exact time of sampling and processing of the samples, storage of processed samples for further analysis, and, if possible, documentation of patient outcome after 7 days. The following steps are carried out after completion of the clinical part of the study in the individual patient or, when possible, in all patients together or in a subset: Bioanalytics, DNA Counts, assessing primary and secondary study endpoints, pharmacometric analyses including PK parameter estimation, PD parameter estimation and assessment of covariate effects with regard to DNA count, CRP, IL-6 and procalcitonin.
Study Type
OBSERVATIONAL
Enrollment
120
Blood samples will be taken to assess antimicrobial drug concentrations and microbial DNA blood counts. Per patient, at least 5 and up to 15 samples for drug concentrations and at least 3 and up to 6 samples for DNA counts are taken for a duration of up to 3 days.
Klinik für Anaesthesiologie, Klinikum der Ludwig-Maximilians-Universität München
Munich, Bavaria, Germany
NOT_YET_RECRUITINGClinical Infectiology, Klinik I für Innere Medizin, University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany
RECRUITINGKlinik für Anästhesiologie und Operative Intensivmedizin Krankenhaus Köln-Merheim Klinikum der Universität Witten/ Herdecke
Cologne, North Rhine-Westphalia, Germany
Fraction of eligible patients
Fraction of identified and potentially eligible patients willing and able to provide informed consent
Time frame: Screening
Positive blood microbial DNA count
Fraction of study participants having any positive blood microbial DNA count for microbes which does not reflect sample contamination
Time frame: Samples for DNA counts are taken for a duration of up to 3 days.
Fraction of patients with at least three samples with microbial DNA
Fraction of study participants with at least three samples with quantifiable microbial DNA along with a proper documentation
Time frame: Samples for DNA counts are taken for a duration of up to 3 days.
Plausible time courses of antimicrobial drug concentrations
Fraction of study participants with plausible time courses of antimicrobial drug concentrations along with a proper documentation
Time frame: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.
Population pharmacokinetic parameters of drugs studied
Pharmacometric analyses including PK parameter estimation
Time frame: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.
Population pharmacodynamic parameters of drugs studied
Population pharmacodynamic parameters of drugs studied with regard to bacterial DNA count, procalcitonin, IL-6 and C-reactive protein
Time frame: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.
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Universitätsklinikum Leipzig AöR, Klinik für Gastroenterologie und Rheumatologie, Sektion Hepatologie
Leipzig, Saxony, Germany
RECRUITING