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| Name | Class |
|---|---|
| Cttq | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | septic shock patients; | ||
| Conrol Group | non-septic shock patients; |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 3, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial eradication | blood and respiratory secretions culture | Baseline, Day 3, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | the outcomes of the patients will be recorded | 28-mortality and 60-mortality |
Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed as severe pneumonia requiring mechanical ventilatory support.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haibo Qiu, PHD | Contact | 8602583262550 | haiboq2000@163.com | |
| Yingzi Huang, PHD | Contact | 8602583262550 | Yz_huang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingzi Yingzi, PHD | Southeast University | Principal Investigator |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |