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Linezolid PK/PD in Morbidly Obese Patients with MRSA Pneumonia
NCT01805284Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2013
- Primary completion
- Sep 2016
- Countries
- 1
- Sponsor
- Ghent University
- Modality
- Small Molecules
- Drugs
- linezolid
- Conditions
- Methicillin-resistant Staphylococcus aureus pneumonia
01
Overview
Phase 4, open-label, single-arm trial of linezolid in Methicillin-resistant Staphylococcus aureus pneumonia, sponsored by Ghent University. Primary endpoints: Time above Minimum Inhibitory Concentration at 72 hours, Pharmacokinetics/dynamics in urine at 12 hours and 2 more. Started Feb 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Linezolid
Patients receiving standard of care Linezolid 600mg IV BID.
03
Who it enrols
Adult morbidly obese patients (BMI > 35) with radiographically and clinically documented MRSA pneumonia who are scheduled to receive at least 6 doses of intravenous linezolid.
04
Endpoints
Primary
Time above Minimum Inhibitory Concentration
Pharmacokinetics/dynamics in urine
Area Under the Curve to Minimum Inhibitory Concentration Ratio
Probability of Target Attainment
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