1. Safety and tolerability of linezolid in children
- Author
-
Kenneth Wible, Lisa Saiman, Sharon Naberhuis-Stehouwer, Jon B. Bruss, Johhanna Goldfarb, Sheldon A Kaplan, and Barbara Edge-Padbury
- Subjects
Male ,Administration, Oral ,Bacteremia ,chemistry.chemical_compound ,Anti-Infective Agents ,Acetamides ,Multicenter Studies as Topic ,Child ,Infusions, Intravenous ,Respiratory Tract Infections ,Randomized Controlled Trials as Topic ,Antibacterial agent ,Cross Infection ,Headache ,Anti-Bacterial Agents ,Community-Acquired Infections ,Infectious Diseases ,Tolerability ,Child, Preschool ,Vancomycin ,Female ,medicine.symptom ,medicine.drug ,Diarrhea ,Microbiology (medical) ,medicine.medical_specialty ,Adolescent ,Internal medicine ,medicine ,Humans ,Adverse effect ,Gram-Positive Bacterial Infections ,Oxazolidinones ,business.industry ,Cefadroxil ,Infant, Newborn ,Linezolid ,Infant ,Pneumonia ,Skin Diseases, Bacterial ,biochemical phenomena, metabolism, and nutrition ,medicine.disease ,Surgery ,Otitis Media ,Upper respiratory tract infection ,Otitis ,chemistry ,Pediatrics, Perinatology and Child Health ,business - Abstract
BACKGROUND Linezolid, an oxazolidinone, is effective in the treatment of adults and children with community-acquired and nosocomial pneumonia and uncomplicated and complicated skin and skin structure infections (SSSIs), including infections caused by Gram-positive resistant pathogens. Because of the increasing use of linezolid, it is important to review the common adverse events (AEs) associated with its use in children with the use of data from clinical trials. OBJECTIVE The safety and tolerability of linezolid in pediatric patients with Gram-positive infections were determined in four pediatric clinical studies. Study I included pediatric patients with community-acquired pneumonia; Study II included otitis media; Study III included SSSIs; and Study IV included complicated SSSIs, nosocomial pneumonia and bacteremia. METHODS Studies I and II had no comparator arm. Study III was randomized and compared linezolid with cefadroxil. Study IV also was randomized and compared linezolid with vancomycin. Patients
- Published
- 2003
- Full Text
- View/download PDF