not applicable
Conditions
Interventions
None listed
Sponsors
Gelre Ziekenhuizen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >18 years; 2. Treatment at regular dosing intervals with intravenous or oral clindamycin for at least 48 hours on day 0 (see Study procedures).; 3. Having signed the Informed Consent form.
Exclusion criteria
Exclusion criteria: 1. Administration of medication with a known pharmacokinetic interaction ( e.g. rifampicin, HIV protease inhibitors).; 2. Inability to understand the nature of the trial and the procedures required.; 3. Self-reported pregnancy.;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance and volume of distribution. These parameters will be estimated from the measured plasma concentrations by nonlinear mixed effect modelling. Plasma concentrations will be measured by a validated method using liquid chromatography * tandem mass spectrometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Absorption rate constant and oral bioavailability. * Body weight (kg), height (cm). These parameters will be used for BMI classification and to explore the optimal weight scaling factor (e.g. TBW, LBW, ABW, etc.). * Multi-frequency bioelectrical impedance analysis (MBIA) will be used to determine body composition. Fractional masses (intracellular/extracellular water, fat) are explored as alternative weight scaling factors. The MBIA will not be used in case of an implanted cardioverter defibrillator (ICD) or when standardized measurement is not possible for practical reasons. * Unbound clindamycin fraction, calculated from the total and free plasma concentration of clindamycin before and after separation of plasma proteins. | — |
Countries
Netherlands
Outcome results
None listed