Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NOS-1001 | Other Identifier | Basilea Internal Reference |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to measure the levels of ceftobiprole in the blood and urine during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.
Patients will receive an intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of ceftobiprole in the plasma. Pharmacokinetic parameters such as clearance and volume of distribution will be calculated. 1000mg every 8hours or every 12 hours
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftobiprole q12h | Experimental | Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2 |
|
| Ceftobiprole q8h | Experimental | Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftobiprole q12h | Drug | Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated throughout the study. | 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ceftobiprole q8h | Drug | Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2 |
|
| Chicago |
| Illinois |
| United States |
| Beech Grove | Indiana | United States |
| Omaha | Nebraska | United States |
| Aalst | Belgium |
| Edegem | Belgium |
| Greenfield Park | Quebec | Canada |
| Jerusalem | Israel |
| Gwangju | South Korea |
| Incheon | South Korea |
| Seoul | South Korea |
| Barcelona | Spain |
| Madrid | Spain |