Advertisement

Topics

Pharmacokinetic Study of the Penetration of Ceftobiprole in the Bone

2014-08-27 03:27:01 | BioPortfolio

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.

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Hip Replacement, Total

Intervention

Ceftobiprole

Status

Completed

Source

Ortho-McNeil Janssen Scientific Affairs, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:27:01-0400

Clinical Trials [979 Associated Clinical Trials listed on BioPortfolio]

An Exploratory Study to Evaluate the Penetration of Ceftobiprole Into Soft Tissue Determined by In Vivo Microdialysis in Healthy Volunteers

The primary objective of this study is to measure the penetration of ceftobiprole into subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration over time o...

Ceftobiprole in the Treatment of Hospital-Acquired Pulmonary Infections

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with nosocomial pneumonia.

Ceftobiprole in the Treatment of Hospital-Acquired Pulmonary Infections

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with nosocomial pneumonia.

Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Saf...

Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia

The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.

PubMed Articles [6448 Associated PubMed Articles listed on BioPortfolio]

The effect of rheumatoid arthritis on patient-reported outcomes following knee and hip replacement: evidence from routinely collected data.

To compare outcomes of total knee replacement (TKR) and total hip replacement (THR) for individuals with RA and OA.

The Association of Body Mass Index with Risk of Long-Term Revision and 90-Day Mortality Following Primary Total Hip Replacement: Findings from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.

The influence of obesity on outcomes following total hip replacement is unclear. Restriction of total hip replacement on the basis of body mass index (BMI) has been suggested. The purpose of this stud...

American Joint Replacement Registry Risk Calculator Does Not Predict 90-day Mortality in Veterans Undergoing Total Joint Replacement.

The American Joint Replacement Registry (AJRR) Total Joint Risk Calculator uses demographic and clinical parameters to provide risk estimates for 90-day mortality and 2-year periprosthetic joint infec...

Development of metabolic syndrome after bilateral total thyroidectomy despite the l-t4 replacement therapy: A prospective study.

The literature about the frequency of metabolic syndrome in patients with multinodular goitre and a new onset of metabolic syndrome after total thyroidectomy is limited. The aim of this study was to i...

Patient Risk Factors Do Not Impact 90-Day Readmission and Emergency Department Visitation After Total Ankle Arthroplasty: Implications for the Comprehensive Care for Joint Replacement (CJR) Bundled Payment Plan.

The Comprehensive Care for Joint Replacement (CJR) model provides bundled payments for in-hospital care and care within 90 days following discharge for Medicare beneficiaries undergoing lower-extremit...

Medical and Biotech [MESH] Definitions

Partial or total replacement of a joint.

Partial or total replacement of one or more FINGERS, or a FINGER JOINT.

The replacement of intervertebral discs in the spinal column with artificial devices. The procedure is done in the lumbar or cervical spine to relieve severe pain resulting from INTERVERTEBRAL DISC DEGENERATION.

Partial or total replacement of the CORNEA from one human or animal to another.

Partial or total replacement of all layers of a central portion of the cornea.

More From BioPortfolio on "Pharmacokinetic Study of the Penetration of Ceftobiprole in the Bone"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Osteoporosis
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial