Staphylococcal Skin Infections Clinical Trial
Official title:
An Open-Label Pharmacokinetic Study of Ceftobiprole in Healthy Volunteers and Patients With End Stage Renal Disease Receiving Hemodialysis
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.
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. ;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01419184 -
Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA
|
Phase 4 | |
| Completed |
NCT00210899 -
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
|
Phase 3 | |
| Recruiting |
NCT02566928 -
Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
|
Phase 4 | |
| Completed |
NCT00228982 -
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
|
Phase 3 | |
| Completed |
NCT01105767 -
Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees
|
N/A | |
| Completed |
NCT00475930 -
Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates
|
N/A | |
| Completed |
NCT02814916 -
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
|
Phase 3 | |
| Completed |
NCT00513799 -
The Natural History of Community-Associated MRSA Infections and Decolonization Strategies
|
N/A | |
| Completed |
NCT00737269 -
A Complicated Skin and Soft-tissue Infection Patient Registry
|
Phase 4 | |
| Completed |
NCT00719810 -
Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
|
Phase 2 | |
| Terminated |
NCT00492271 -
First Time in Man Trial for Friulimicin B
|
Phase 1 | |
| Completed |
NCT01026740 -
Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00731783 -
Staphylococcus Aureus Decolonization Study
|
N/A | |
| Completed |
NCT01018641 -
An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults
|
Phase 1 | |
| Terminated |
NCT00463801 -
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
|
Phase 4 | |
| Completed |
NCT02582203 -
Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA
|
Phase 4 | |
| Completed |
NCT00646958 -
Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
|
Phase 2 | |
| Completed |
NCT01026636 -
A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age
|
Phase 1 | |
| Completed |
NCT01026558 -
A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients
|
Phase 1 | |
| Completed |
NCT00514527 -
A Study for Patients With Complicated Skin and Skin Structure Infections
|
Phase 2 |