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Clinical Trials/EUCTR2011-000158-47-AT
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.

Registry
who.int
Start Date
December 16, 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Klin. Abtlg. für Thorax- & Hyperbare Chirurgi

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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