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

niversity Ghent0 个研究点目标入组 20 人开始时间: 2012年11月12日最近更新: 2017年8月21日

试验速览

暂无简介。

•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
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•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.

发起方

niversity Ghent