Daptomycin concentration in drainage fluid and blood samples of ICU patients
- Conditions
- Intensive Care Patients after Surgery treated with Daptomycin and wound draingaeTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-000125-36-DE
- Lead Sponsor
- niversity Hospital Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9
* Patients = 18 /< 85 years old
* postoperative patients
* written consens of patient or their legal assistance
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
Schwangerschaft (Ausschluss per routinemäßigem Schwangerschaftstest bei weiblichen Notfallpatientinnen < 50 Jahre bzw. per präoperativ erhobener Anamnese)
* handicaped patients
* breast feeding patients
* age <18 / > 85 years
* documented allergy to daptomycin
* acute rhabdomyolysis (increase in Kreatinphosphokinase and Laktatdehydrogenase > fivefold of upper limit: Kreatinphosphokinase >950U/l, Laktatdehydrogenase >1250 U/l)
* patients dependent on sponsor, manufactor or principle investigator or their relatives
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Pharmakokinetics of Daptomycin in intensive care patients with wound drainage after surgery;Secondary Objective: Incidence of gram-positive infection; LOS ICU LOS Hospital;Primary end point(s): Pharmakokinetic of daptomycin in blood; elimination of daptomycin n drainage;Timepoint(s) of evaluation of this end point: Postoperative day 1-3
- Secondary Outcome Measures
Name Time Method Secondary end point(s): LOS ICU and hospital;Timepoint(s) of evaluation of this end point: Release of ICU and relase of hospital