Pharmacokinetics of clindamycin in overweight patients

Completed

Conditions: not applicable
10004018

Registration Number: NL-OMON45669

Lead Sponsor: Gelre Ziekenhuizen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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.;

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clearance and volume of distribution. These parameters will be estimated from<br /><br>the measured plasma concentrations by nonlinear mixed effect modelling. Plasma<br /><br>concentrations will be measured by a validated method using liquid<br /><br>chromatography * tandem mass spectrometry.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Absorption rate constant and oral bioavailability.<br /><br>* Body weight (kg), height (cm). These parameters will be used for BMI<br /><br>classification and to explore the optimal weight scaling factor (e.g. TBW, LBW,<br /><br>ABW, etc.).<br /><br>* Multi-frequency bioelectrical impedance analysis (MBIA) will be used to<br /><br>determine body composition. Fractional masses (intracellular/extracellular<br /><br>water, fat) are explored as alternative weight scaling factors. The MBIA will<br /><br>not be used in case of an implanted cardioverter defibrillator (ICD) or when<br /><br>standardized measurement is not possible for practical reasons.<br /><br>* Unbound clindamycin fraction, calculated from the total and free plasma<br /><br>concentration of clindamycin before and after separation of plasma proteins.</p><br>