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Pharmacokinetic Study of the Penetration of Ceftobiprole in the Bone

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ClinicalTrials.gov Identifier: NCT00771524
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica

Tracking Information
First Submitted Date  ICMJE October 10, 2008
First Posted Date  ICMJE October 13, 2008
Last Update Posted Date July 30, 2012
Study Start Date  ICMJE April 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
The primary objective is to estimate the penetration of ceftobiprole into bone in otherwise healthy patients who are undergoing total hip replacement surgery.
Change History Complete list of historical versions of study NCT00771524 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
Safety and tolerability will also be assessed. [ Time Frame: 1 week ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
Safety and tolerability will also be assessed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study of the Penetration of Ceftobiprole in the Bone
Official Title  ICMJE Open-Label, Pharmacokinetic Study of the Penetration of Ceftobiprole Into Bone
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 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Total Hip Replacement Surgery
Intervention  ICMJE Drug: Ceftobiprole
Ceftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery
Study Arms  ICMJE
  • Experimental: Ceftobiprole
    Ceftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery
    Intervention: Drug: Ceftobiprole
  • No Intervention: Control
    Standard of care antibiotics prior to hip replacement surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2010)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2008)
20
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00771524
Other Study ID Numbers  ICMJE CR014227
PED-1001 ( Other Identifier: Basilea Internal Reference )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Basilea Pharmaceutica
Study Sponsor  ICMJE Basilea Pharmaceutica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
PRS Account Basilea Pharmaceutica
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP