Tedizolid phosphate for the management of acute bacterial skin and skin structure infections: safety summary.
Clin Infect Dis
; 58 Suppl 1: S51-7, 2014 Jan.
Article
in En
| MEDLINE
| ID: mdl-24343833
ABSTRACT
The novel oxazolidinone tedizolid phosphate is in late-stage clinical development. In an effort to improve efficacy and safety, the adverse event profile and safety aspects of tedizolid phosphate have been evaluated in several preclinical animal models and through ongoing clinical trials. Early dose-ranging studies demonstrated a favorable overall adverse event profile and low thrombocytopenia rates, which have been consistently confirmed in phase 2 and 3 clinical trials. Pharmacokinetic modeling suggests a lower potential for monoamine oxidase interaction, and animal and human subject testing has confirmed these predictions. Studies in special patient populations showed a consistent and predictable pharmacokinetic profile across age groups and comorbid conditions, without evidence of increased incidence of adverse effects over matched controls. The favorable safety profile makes tedizolid phosphate an important new option for the management of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Oxazoles
/
Organophosphates
/
Staphylococcal Skin Infections
/
Anti-Bacterial Agents
Type of study:
Prognostic_studies
Limits:
Animals
/
Humans
Language:
En
Journal:
Clin Infect Dis
Journal subject:
DOENCAS TRANSMISSIVEIS
Year:
2014
Document type:
Article