MRSA-positive, morbidly obese patients with pneumonia MedDRA version: 14.1 Level: LLT Classification code 10053024 Term: Pneumonia gram-positive bacterial System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Zyvoxid 2mg/ml oplosssing voor infusie
Product Name: Linezolid
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Linezolid
Other descriptive name: LINEZOLID
Concentration uni
Sponsors
University Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the linezolid unbound and total plasma levels and their variability in MRSA-positive, morbidly obese patients with pneumonia, after repeated intravenous administration of linezolid. ;Secondary Objective: Determination of the probability of PK/PD target attainment (PTA) by MIC against MRSA. ;Primary end point(s): Pharmacokinetics and pharmacodynamics of linezolid ;Timepoint(s) of evaluation of this end point: Blood samples collection during 84 hours after administration of the first dose of linezolid 12 hour urine collection after administration of the 6th or 7th dose of linezolid | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Determination of linezolid MICs ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Belgium
Contacts
Public ContactTrial Bureau
University Ghent
Outcome results
None listed