Primary Objective: To develop a pharmacokinetic model of clindamycin in patients of different BMI categories to determine the relevant obesity related covariates. Secondary Objective(s):To determine the variability and influence of clindamycin…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* 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.
Background summary
Obesity is a worldwide problem for years. 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 [2,3]. Because of the growing problem of obesity
clinicians face the fact that there isn*t 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. To date sufficient and
specific pharmacokinetic data on clindamycin in obese patients are lacking. It
is plausible that current dosing regimens lead to sub-therapeutic plasma
concentrations and consequently inadequate treatment in the growing obese
population
Study objective
Primary Objective: To develop a pharmacokinetic model of clindamycin in
patients of different BMI categories to determine the relevant obesity related
covariates.
Secondary Objective(s):
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 burden and risks
The risks for participating in this study are considered to be minimal. There
are no direct benefits of this study for the study patients. The results of the
study will provide insight into the pharmacokinetics of clindamycin in
overweight patients.
Albert Schweitzerlaan 31
Apeldoorn 7334DZ
NL
Albert Schweitzerlaan 31
Apeldoorn 7334DZ
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-000588-34-NL |
| CCMO | NL61042.091.17 |
| OMON | NL-OMON20286 |