PHARMACOKINETICS OF INTRAVENOUS CEFOTAXIME IN CHILDRE

Recruiting

• Conditions: 10017528; bacterial infectious diseases; bacterial infections

• Registration Number: NL-OMON34521
• Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1. Patients who receive intravenous treatment with cefotaxime
2. Patients < 18 years
3. Written informed consent from the patient and/or their legal guardian

Exclusion Criteria

Patients with a known allergy to cefotaxime or related compounds

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameters in this study will be:<br /><br>* T1/2 (half-life during elimination phase) and Vss (volume of distribution in<br /><br>steady state) of cefotaxime and desacetyl-cefotaxime<br /><br>* Total body clearance, AUC (area under the time-concentration curve), MRT<br /><br>(mean residence time)<br /><br><br /><br>Interpretation of pharmacokinetic parameters<br /><br>* Plasma concentrations and AUC*s of cefotaxime will be compared to the MIC<br /><br>(minimal inhibitory concentration) of the microbe to be eliminated<br /><br>* Cefotaxime/desacetyl-cefotaxime (cef/des ratio) ratio*s will be calculated to<br /><br>determine liver metabolism<br /><br>* The T1/2 of cefotaxime and desacetyl-cefotaxime will be related to the GFR<br /><br>(glomerular filtration)<br /><br>* All pharmacokinetic parameters will be related to the personal<br /><br>characteristics of the subjects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>