Assessment of extracellular concentrations of linezolid and other currently approved antibiotics in patients presenting with severe bacterial lung infectio

• Conditions: Subjects who are scheduled to undergo elective open-chest lung surgery will be includedin the study.

• Registration Number: EUCTR2011-000158-47-AT
• Lead Sponsor: Klin. Abtlg. für Thorax- & Hyperbare Chirurgi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
inhibitors (SSRIs) and selective serotonin and noradrenalin reuptake inhibitors (SNRIs)
9. Patients unable or unwilling to adhere to the study-designated procedures and restrictions.
10. Breast-feeding women
11. Treatment with medications that inhibit monoamine oxidases A or B in the past two weeks.
12. Patients with uncontrolled hypertension, pheochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute state of confusion.
13. Treatment with serotonin reuptake inhibitors, tricyclic antidepressants or 5-hydroxytryptamine/serotonin1B/1D (5-HT1B/1D) agonists

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the pharmacokinetic (PK) profile of linezolid and other currently approved<br>antibiotics in the extracellular space fluid of infected lung and unaffected<br>subcutaneous adipose tissue at steady-state conditions;Secondary Objective: Secondary objectives:<br>• To determine free blood levels of linezolid and other currently approved antibiotics.<br>Further, to correlate these levels to minimal inhibitory concentrations of clinically<br>relevant bacteria.<br>• To calculate relevant PK/pharmacodynamic (PK/PD) indices for the prediction of<br>clinical and microbiological efficacy;Primary end point(s):