NCT03308227

Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 46 (estimated)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on PK/PD of linezolid.

Detailed description

A wide array of pathophysiological changes occurring in severe sepsis and septic shock patients may influence antibiotics' pharmacokinetic (PK) properties. The pharmacokinetics and tissue distributions of linezolid achieving effective concentrations are key factors of successful clinical outcomes. To the best of our knowledge, no observational clinical studies are available on the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients. Severe pneumonia patients known or suspected to be caused by Gram-positive pathogens will be considered eligible for the study when the attending physician prescribed linezolid as treatment. The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state. In an in vitro PK Model, concentration-time curve is drawn to calculate %T\>MIC or AUC0-24h/MIC. Linezolid pharmacodynamics evaluation should be based on bacterial eradication and clinical outcomes.

Conditions

• Septic Shock

Timeline

• Start date: 2017-10-20
• Primary completion: 2018-02-28
• Completion: 2018-04-30
• First posted: 2017-10-12
• Last updated: 2017-10-12