Clinical Trials Logo

Clinical Trial Summary

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 of ceftobiprole in these tissues and in plasma after administration of a single intravenous (i.v.) infusion (directly into the vein) of ceftobiprole 500 mg administered over 2 hours. The secondary objective was to further assess the safety and tolerability of ceftobiprole after a single i.v. infusion.


Clinical Trial Description

This is a single-center, open-label (all patients involved know the identity of the drug), single-arm, nonrandomized study of ceftobiprole in healthy men and women. The study is conducted in 2 parts: a pilot study and a main study. Each study (i.e. the pilot study and the main study) consists of 3 phases: a pretreatment phase that includes up to a 21-day screening period, an open-label treatment phase (1 day in the pilot study and 2 days in the main study), and a posttreatment phase that included the end of study evaluations and follow-up study visit or telephone contact planned for 1 to 2 weeks after discharge from the study unit. Serial blood and dialysis samples will be collected at specified time points from predose through 24 hours after the start of the infusion for estimation of ceftobiprole and ceftobiprole medocaril concentrations. Additional samples will be collected for measurement of protein binding. The study will include the following evaluations of safety and tolerability: adverse events, clinical laboratory tests (including hematology, serum chemistry, and urinalysis), electrocardiogram (ECG), vital signs, physical examination, serology, pregnancy tests, urine drug screen, and alcohol breath test. In the pilot study, Ceftobiprole will be locally administered via a microdialysis probe at a concentration of approximately 30 µg/mL for 60 minutes. In the main Study, each volunteer will receive ceftobiprole locally via the microdialysis probe. After the washout period determined by the pilot study, each volunteer will receive a single 2-hour i.v. infusion of ceftobiprole. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01026740
Study type Interventional
Source Basilea Pharmaceutica
Contact
Status Completed
Phase Phase 1
Start date June 2007
Completion date September 2007

See also
  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 NCT01030731 - Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease Phase 1
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 NCT00719810 - Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections Phase 2
Completed NCT00737269 - A Complicated Skin and Soft-tissue Infection Patient Registry Phase 4
Terminated NCT00492271 - First Time in Man Trial for Friulimicin B 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 NCT01026558 - A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients Phase 1
Completed NCT01026636 - A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age Phase 1
Completed NCT00514527 - A Study for Patients With Complicated Skin and Skin Structure Infections Phase 2