|- candidate number||28574|
|- NTR Number||NTR7055|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-feb-2018|
|- Secondary IDs||NL2017-000588-34 CP2016APO04|
|- Public Title||Concentratie van clindamycine in bloed bij patiŽnten met overgewicht|
|- Scientific Title||Pharmacokinetics of clindamycin in overweight patients|
|- hypothesis||0-hypothesis: no clinically relevant difference in clindamycin exposure (AUC/MIC) in overweight patients using 70 kg as a reference body weight|
|- Healt Condition(s) or Problem(s) studied||Obesity, Infection, Overweight, Pharmacokinetics, Clindamycine|
|- Inclusion criteria||- Age > 18 years |
- Treatment at regular dosing intervals with intravenous or oral clindamycin for at least 48 hours on day of blood sampling. Subject can be included twice if route of administration changes.
- Having signed the Informed Consent form.
|- Exclusion criteria||- Administration of medication with a known pharmacokinetic interaction ( e.g. rifampicin, HIV protease inhibitors.|
- Inability to understand the nature of the trial and the procedures required.
- Self-reported pregnancy
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||29-jan-2018|
|- planned closingdate||31-jan-2019|
|- Target number of participants||40|
|- Primary outcome||Non-linear mixed effect pharmacokinetic model|
|- Secondary outcome||- Variability of plasma protein binding|
- Pharmacokinetic target achievement
|- Timepoints||0, 0.5, 1, 1.5, 2, 4, 6 and 8 hours after administration|
|- Trial web site||n.a.|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PharmD PhD H.J.M. van Kan|
|- CONTACT for SCIENTIFIC QUERIES||PharmD PhD H.J.M. van Kan|
|- Sponsor/Initiator ||Gelre hospital Apeldoorn|
(Source(s) of Monetary or Material Support)
|Gelre hospital Apeldoorn|
|- Brief summary||Rationale: To date sufficient and specific pharmacokinetic data on clindamycin in obese patients are lacking. Obesity is a widely recognized worldwide problem. Besides the risk of an increased body mass index (BMI) on the development of cardiovascular diseases, diabetes and different types of cancer, it is well known that obesity is associated with inflammatory processes [3,4]. Because of the growing problem of obesity clinicians face the fact that there isnít much information available to make the right dosing decisions in obese patients. Obesity is associated with pathophysiological changes that can influence pharmacokinetics of drugs in important matter. Clindamycin is a lincomycin antibiotic and is effective against anaerobe and Gram-positive aerobe bacteria. It is plausible that current dosing regimens lead to sub-therapeutic plasma concentrations and consequently inadequate treatment in the growing obese population
Objective: Primary Objective: To determine the pharmacokinetics of clindamycin in patients of different weight categories who are treated for an infection caused by a clindamycin susceptible pathogen
∑ To determine the variability and influence of clindamycin plasma protein binding
∑ To compare the pharmacokinetic target achievement by using modelling and simulation.
Overall Aim: To develop rational dosing regimens for clindamycin in patients of different body weight classification.
Study design: This project is a prospective open multi-center observational cohort study.
Study population: Hospitalized patients (≥18 years old) with an infection treated with intravenous or oral clindamycin.
Main study parameters/endpoints: Clearance and distribution volume. Secondary parameters are absorption rate constant, bioavailability, weight, height, unbound clindamycin fraction and body composition. These parameters will be estimated from the measured plasma concentrations by non-compartimental analysis and nonlinear mixed effect modelling. Plasma concentrations will be measured by a validated method using liquid chromatography Ė tandem mass spectrometry.
|- Main changes (audit trail)|
|- RECORD||14-feb-2018 - 11-mrt-2018|