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Results from previous studies have been inconclusive and the effect of linezolid on cytokines remains unclear. This study is designed to evaluate the effect of linezolid on the functionality of white blood cells (neutrophils and monocytes) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator |
| |
| Arm B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linezolid | Drug | 600 mg oral tablet twice daily for 4.5 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in phagocytosis of gram-negative bacteria by neutrophils | Baseline, day 4 and day 5 | |
| Change from baseline in phagocytosis of gram-negative bacteria by monocytes | Baseline, day 4 and day 5 | |
| Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 | |
| Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 | |
| Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 | |
| Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 | |
| Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation | Baseline, day 4 and day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Linezolid peak concentration on day 4 | day 4 | |
| Linezolid peak concentration on day 5 | day 5 | |
| Linezolid trough concentration on day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Placebo | Drug | 500 mg oral placebo twice daily for 4.5 days |
|
| day 5 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |