Pharmacokinetic and pharmacodynamic evaluation of linezolid administered intravenously in MRSA-positive, morbidly obese patients with pneumonia.

niversity Ghent0 sites20 target enrollmentNovember 12, 2012

Overview

No summary available.

Registry

who.int

Start Date

November 12, 2012

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Ghent

•Patient age 18 years or more
•BMI \>35 (BMI \= weight (kg) / height2 (m2\))
•Radiographically and clinically documented pneumonia and one of the following:
•\- the patient is MRSA screen\-positive and is as such at high risk for MRSA pneumonia (MIC for linezolid is known or possible to assess)
•\- the patient has a baseline respiratory tract sample positive for MRSA; MRSA pneumonia is likely
•\- empiric therapy without linezolid is initiated (no obvious indication for MRSA involvement), but the patient is switched to linezolid therapy once culture results demonstrate MRSA as pathogen. CAVE: the patients must be included in the study prior to the moment the first trough sample must be drawn. As such, patients becoming MRSA\-positive after \>1 dose of linezolid cannot be included in the study.
•Decision to start treatment with linezolid for at least 3 days (6 doses of 600 mg).
•Patient is colonized or infected with MRSA (at any site) and it must be possible to send a fresh isolate to the central laboratory for microbiology
•Written informed consent by the patient or his/her legal representative.
•Are the trial subjects under 18? no

•Exclusion from participation in the study is left at the discretion of the treating physician.
•Contraindications as described in the SmPC may serve as a basis for patient exclusion.