An observational study in Septic Shock, sponsored by Southeast University, China. Status unknown. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-12.
Sponsored by Southeast University, China · Observational
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.
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.
Patients diagnosed as severe pneumonia requiring mechanical ventilatory support.
Exclusion Criteria:
septic shock patients;
non-septic shock patients;
The plasma and bronchoalveolar lavage fluid concentrations of linezolid
The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state
Time frame: Baseline, Day 3, Day 7
Bacterial eradication
blood and respiratory secretions culture
Time frame: Baseline, Day 3, Day 7
mortality
the outcomes of the patients will be recorded
Time frame: 28-mortality and 60-mortality
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Southeast University, China