Pharmacokinetic Study of the Penetration of Ceftobiprole in the Bone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00771524
First received: October 10, 2008
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 piece of your hip bone which will be removed as part of your surgery will be analyzed to determine how much ceftobiprole gets into the bone.


Condition Intervention Phase
Total Hip Replacement Surgery
Drug: Ceftobiprole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Open-Label, Pharmacokinetic Study of the Penetration of Ceftobiprole Into Bone

Resource links provided by NLM:


Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • The primary objective is to estimate the penetration of ceftobiprole into bone in otherwise healthy patients who are undergoing total hip replacement surgery. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability will also be assessed. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftobiprole
Ceftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery
Drug: Ceftobiprole
Ceftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery
No Intervention: Control
Standard of care antibiotics prior to hip replacement surgery

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 remaining 18 patients will receive ceftobiprole 500 mg dripped into the vein over 2 hours. All patients will have a sample of bone taken during the surgery and blood samples taken at specific timepoints. The samples taken from the 2 patients who did not receive study drug will assist in the development of a test used to measure the study drug in the bone sample. This is an open-label, parallel group, pharmacokinetic study in healthy men and women who have been cleared medically for elective total hip replacement surgery. Healthy is defined as patients who are medically stable and cleared for elective surgery. The study has 4 phases: a screening phase of up to 21 days before the day of surgery; a pretreatment phase of up to 7 days before the day of surgery; a 1-day open-label treatment phase; an end-of-study phase (end-of-study procedures or at the time of early withdrawal); and a follow-up telephone contact approximately 1 week after the surgery to assess new and ongoing adverse events. Two control subjects will be enrolled; these patients will not receive ceftobiprole, but will undergo surgery and a bone sample, which will serve as a control for qualifying the bioanalytical assay. The remaining 36 patients will be randomized to 1 of 2 ceftobiprole treatments. The primary objective is to estimate the penetration of ceftobiprole into bone of otherwise healthy patients who are undergoing total hip replacement surgery. Safety and tolerability will also be assessed. Venous blood samples will be collected and analyzed for ceftobiprole concentrations using validated liquid-chromatography methodology, with tandem mass spectrometric detection. Bone samples will be analyzed for ceftobiprole by qualified liquid-chromatography methodology, with tandem mass spectrometric detection. Safety and tolerability will be evaluated throughout the study. Blood will be drawn for clinical laboratory tests and PK evaluations. A single dose of ceftobiprole 500 mg dripped into the vein over 2 hours, administered prior to elective hip replacement surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771524

Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
  More Information

No publications provided

Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT00771524     History of Changes
Other Study ID Numbers: CR014227, PED-1001
Study First Received: October 10, 2008
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Basilea Pharmaceutica:
Pharmacokinetics
Hip replacement
Ceftobiprole

Additional relevant MeSH terms:
Ceftobiprole
Ceftobiprole medocaril
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014