NCT00771524

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

October 10, 2008

Last Update Submit

July 27, 2012

Conditions

Total Hip Replacement Surgery

Keywords

PharmacokineticsHip replacementCeftobiprole

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to estimate the penetration of ceftobiprole into bone in otherwise healthy patients who are undergoing total hip replacement surgery.

    1 week

Secondary Outcomes (1)

  • Safety and tolerability will also be assessed.

    1 week

Study Arms (2)

Ceftobiprole

EXPERIMENTAL

Ceftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery

Drug: Ceftobiprole

Control

NO INTERVENTION

Standard of care antibiotics prior to hip replacement surgery

Interventions

CeftobiproleDRUG

Ceftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery

Ceftobiprole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

ceftobiprole

Study Officials

  • Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

    Ortho-McNeil Janssen Scientific Affairs, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2008

First Posted

October 13, 2008

Study Start

April 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

July 30, 2012

Record last verified: 2012-07