Status:
COMPLETED
Pharmacokinetic Study of the Penetration of Ceftobiprole in the Bone
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Total Hip Replacement Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being performed to measure the amount of the antibiotic ceftobiprole (study drug) found in the bone and blood after receiving one dose prior to your elective hip replacement surgery. A p...
Detailed Description
About 20 patients will take part in the study. Two patients will not receive ceftobiprole, but will receive an antibiotic that is normally given prior to elective hip replacement surgery. The remainin...
Eligibility Criteria
Inclusion
- Healthy men and women at least 18 years of age who have elected to undergo hip replacement surgery. Subjects must be in overall good health with normal renal function (a creatinine clearance of \>50 mL/min).
Exclusion
- Subjects must not have a history of repeated severe nausea with anesthesia, gastric or duodenal ulcer, allergy to b lactam antibiotics, urinary obstruction or difficulty in voiding.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00771524
Start Date
April 1 2009
End Date
February 1 2010
Last Update
July 30 2012
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