THE PHARMACOKINETICS OF DAPTOMYCIN DURING CONTINUOUS VENOVENOUS HEMOFILTRATIO

Conditions: pharmacokinetics of Daptomycin during CVVHF(intensive care patients continuous venovenous haemodiafiltration) in critically ill patients.

Registration Number: EUCTR2009-016092-30-AT

Lead Sponsor: Medizinische Universität Wien, Univ.Klinik f.Innere Medizin I,Abt. f. Infektionen u.Tropenmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Age >18 years
- Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- Continuous venovenous hemofiltration because of an acute renal failure.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known hypersensitivity to daptomycin.
- An expected survival of less than three days.
- Known pregnancy
- Patients being treated with daptomycin only regimen for diagnosis of osteomyelitis, meningitis, enterococci infection or pneumonia without adequate concomitant use of other more effective antimicrobial agents (as daptomycin is not indicated for primary treatment of these types of infections)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to investigate the pharmacokinetics of Daptomycin during CVVHF with high-flux membranes.;Secondary Objective: -;Primary end point(s): -area under the curve (AUC),<br>-half-life (t1/2), <br>-maximum and minimum plasma concentration (Cmax, Cmin),<br>-total body clearance (Cltot), <br>-hemofiltration clearance (ClHF), <br>-sieving coefficient and the elimination fraction.

Secondary Outcome Measures