EUCTR2011-000158-47-AT
Active, not recruiting
Not Applicable
Assessment of extracellular concentrations of linezolid and other currently approved antibiotics in patients presenting with severe bacterial lung infection
Klin. Abtlg. für Thorax- & Hyperbare Chirurgi0 sites40 target enrollmentDecember 16, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Klin. Abtlg. für Thorax- & Hyperbare Chirurgi
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent to participate in the study.
- •2\. Conservative treatment options failed to work well
- •3\. Male or female patient of 18 years of age or older.
- •4\. Scheduled to undergo elective lung surgery
- •5\. Suspected or proven severe bacterial infection
- •6\. Severe sepsis according to ACCP/SCCP guidelines and criteria.
- •7\. Negative urine pregnancy test in females of childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. Treatment with the study drug within the past three weeks prior to study enrolment.
- •2\. Relevant renal dysfunction indicated by a creatinine clearance \= 40 ml/min as determined by
- •the Cockcroft\-Gault equation using actual body weight.
- •3\. Severe hepatic impairment defined by a serum AST \= 150\.
- •4\. Neutrophil count \<1000/µl
- •5\. Thrombocytopenia \< 50 000 /µl
- •6\. HIV, HCV or HBV infection.
- •7\. History of hypersensitivity to the study drug or to drugs with similar chemical structures
- •(oxazolidinones).
- •8\. Treatment with antidepressants belonging to the class of selective serotonin reuptake
Outcomes
Primary Outcomes
Not specified
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