A Phase 4 interventional study of Cefotaxime in Critically Ill, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-27.
Sponsored by University Medical Center Groningen · Phase 4, Interventional, and Basic science
This study evaluates target attainment after either intermittent intravenous bolus or intravenous continuous infusion of cefotaxime in critically ill patients. Critically ill patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.
Critically ill patients have other pharmacokinetic/pharmacodynamic profiles than healthy volunteers. Suboptimal, both under- and overdosing of antibiotics is an important threat in this patient category. Given the time-dependent character of beta-lactam antibiotics continuous dosing as opposed to traditional intermittent dosing is likely to render better target attainment and maintenance and might improve clinical outcome.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
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Cefotaxime 1 gram (1000 mg) is to be administered 4 times daily for 4 days
Drug: Cefotaxime
After a 1 gram (1000 mg) Cefotaxime loading dose, Cefotaxime 4 gram (4000 mg) is to be administered as a continuous infusion in 24h for 4 days .
Drug: Cefotaxime
To assess the influence of administration route on target attainment cefotaxime is administered via two IV routes.
Also known as: Claforan
Cefotaxim serum concentrations
Cefotaxime serum concentrations, total and unbound, will be determined. The Pharmacokinetic/Pharmacodynamic (PK/PD) target of total serum concentration of 4 times above minimal inhibitory concentration (MIC) ascertains that the unbound drug serum concentration will be above the MIC value of 1 mg/mL, which is determined to be the minimum target.
Time frame: 40 min, 1 hour, 2, 4, 8, 12 and 24 hours; 36h; 48 h; 60h; 72h; 84h and 96h post administration
Area under the curve of cefotaxim
Based on the data from the primary outcome measure a pharmacokinetic model for ICU patients will be developed.
Time frame: 0-96h post administration
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen