Status:
COMPLETED
Pharmacokinetic and Pharmacodynamic Evaluation of Linezolid Administered Intravenously in MRSA-positive, Morbidly Obese Patients With Pneumonia
Lead Sponsor:
University Ghent
Collaborating Sponsors:
University Hospital, Ghent
Pfizer
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objectives of the study are: (i) to evaluate the proportion of patients who attain a T\>MIC (Minimum Inhibitory Concentration) of 100% and the time frame in which they do so. The investigators th...
Eligibility Criteria
Inclusion
- BMI \>35
- 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 switch 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 sent a fresh isolate to the central laboratory for microbiology.
- Written informed consent by the patient or his/her legal representative.
- Exclusion:
- Contraindications as described in the summary of product characteristics (SPC).
Exclusion
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01805284
Start Date
February 1 2013
End Date
September 30 2016
Last Update
December 1 2021
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000