Advertisement

Topics

Pharmacokinetic Study of Ceftobiprole in Healthy Volunteers and Patients With End Stage Renal Disease Receiving Hemodialysis

2014-08-27 03:17:19 | BioPortfolio

Summary

The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (ESRD) requiring hemodialysis or healthy volunteers.

Description

The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (ESRD) requiring hemodialysis or healthy volunteers. This is a Phase 1, open label study (all patients involved know the identity of the drug). Healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis. Plasma and urine samples will be assayed for ceftobiprole. Samples will be collected over a 48 hour period of time. Safety evaluations will include monitoring of adverse events, clinical laboratory tests (hematology and serum chemistry in all patients/volunteers, and urinalysis in healthy volunteers subjects), pregnancy testing, vital signs, physical examination, and recording of concomitant medications. Healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Staphylococcal Skin Infections

Intervention

Ceftobiprole

Status

Completed

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:19-0400

Clinical Trials [1091 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...

Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device

Ceftobiprole is a very active new cephalosporin on staphylococci resistant to methicillin (SEMR: Staphylococcus epidermidis Resistant to Meticillin, SAMR: Staphylococcus aureus Resistant t...

Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

The purpose of this study is to compare the safety and efficacy of ceftobiprole medocaril versus vancomycin plus aztreonam in the treatment of patients with acute bacterial skin and skin s...

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.

PubMed Articles [6316 Associated PubMed Articles listed on BioPortfolio]

Multiple neonatal Staphylococcal cold abscesses in large skin folds: a benign neonatal skin infection.

Huber et al. previously reported 3 cases of a benign neonatal skin abscess named multiple neonatal staphylococcal cold abscesses of the large skin folds (MNSCA). Such cases have not been reported sin...

Newest lipoglycopeptides for the management of acute bacterial skin and skin structure infections.

Acute bacterial skin and skin structure infections (ABSSSIs) are some of the most commonly encountered infections worldwide. Hospitalizations as a result of absssi are associated with high mortality. ...

Ascertaining infectious disease burden through primary care clinic attendance among young Aboriginal children living in four remote communities in Western Australia.

Infectious diseases contribute a substantial burden of ill-health in Australia's Aboriginal children. Skin infections have been shown to be common in remote Aboriginal communities, particularly in the...

Current Concepts for the Treatment of Skin and Soft Tissue Infections in Orthopaedic and Trauma Surgery.

Skin and soft tissue infections include the skin as well as fascia, muscles, ligaments, tendons, synovial membranes, fat, blood vessels, nerves, and fibrous tissues. They range from superficial infect...

Invasive Bacterial Infections in Infants Younger Than 60 Days With Skin and Soft Tissue Infections.

The objective of this study was to describe the frequency of invasive bacterial infections (IBIs) in young infants with skin and soft tissue infections (SSTIs) and the impact of IBI evaluation on disp...

Medical and Biotech [MESH] Definitions

Infections to the skin caused by bacteria of the genus STAPHYLOCOCCUS.

A diffuse, non-pitting induration of the skin of unknown etiology that occurs most commonly in association with diabetes mellitus, predominantly in females. It typically begins on the face or head and spreads to other areas of the body, sometimes involving noncutaneous tissues. Often it is preceded by any of various infections, notably staphylococcal infections. The condition resolves spontaneously, usually within two years of onset. (From Dorland, 27th ed)

Infections with bacteria of the genus STAPHYLOCOCCUS.

An antibiotic produced by Streptomyces lincolnensis var. lincolnensis. It has been used in the treatment of staphylococcal, streptococcal, and Bacteroides fragilis infections.

Poisoning by staphylococcal toxins present in contaminated food.

More From BioPortfolio on "Pharmacokinetic Study of Ceftobiprole in Healthy Volunteers and Patients With End Stage Renal Disease Receiving Hemodialysis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Renal disease
Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are non-specific, and might include feeling generally unwell and experi...


Searches Linking to this Trial