title: Linezolid for the treatment of complicated skin and skin structure infections in children.
abstract: BACKGROUND
  Gram-positive pathogens are a major cause of complicated skin and skin structure infections (CSSSIs) in children. Many pathogens are developing decreased susceptibility to currently used antibiotics, increasing the need for new therapies. Linezolid is well-tolerated and effective in the treatment of these infections in adults.
  
  
  OBJECTIVE
  To evaluate the clinical efficacy and safety of iv/oral linezolid and iv vancomycin in children with Gram-positive CSSSIs.
  
  
  METHODS
  Hospitalized children <12 years of age were randomized (2:1 ratio) to receive either linezolid 10 mg/kg iv every 8 h (with the option to change treatment to oral linezolid suspension 10 mg/kg every 8 h) or iv vancomycin 10 to 15 mg/kg every 6 to 24 h (according to age). Clinical response, tolerance and safety were evaluated at follow-up. The results of a subset analysis of patients with CSSSIs are presented here.
  
  
  RESULTS
  One hundred twenty intent-to-treat patients (linezolid 80, vancomycin 40) with CSSSI were included in this analysis. Clinical cure rates for clinically evaluable patients with CSSSI did not differ between treatment groups (linezolid, 93.2% vs. vancomycin, 90.0%; P = 0.594). Significantly fewer linezolid-treated patients experienced drug-related adverse events than did vancomycin-treated patients (23% vs. 48%; P = 0.006). The percentages of patients with laboratory abnormalities, including selected hematologic parameters, were generally low and similar between the treatment groups.
  
  
  CONCLUSIONS
  Linezolid given iv or orally was well-tolerated and safe. It was as effective as vancomycin in treating children with Gram-positive CSSSIs.
authors.affiliation: Children's Memorial Hospital, Chicago, IL, USA.
authors.forename: Ram
authors.initials: R
authors.lastname: Yogev
authors.forename: Lori E
authors.initials: LE
authors.lastname: Patterson
authors.forename: Sheldon L
authors.initials: SL
authors.lastname: Kaplan
authors.forename: Stuart
authors.initials: S
authors.lastname: Adler
authors.forename: Maria Rayo
authors.initials: MR
authors.lastname: Morfin
authors.forename: Amando
authors.initials: A
authors.lastname: Martin
authors.forename: Barbara
authors.initials: B
authors.lastname: Edge-Padbury
authors.forename: Sharon
authors.initials: S
authors.lastname: Naberhuis-Stehouwer
authors.forename: Jon B
authors.initials: JB
authors.lastname: Bruss
mesh_terms: D000081:Acetamides / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000284:Administration, Oral; D000367:Age Factors; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002648:Child; D002675:Child, Preschool; D005260:Female; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D000069349:Linezolid; D008297:Male; D023303:Oxazolidinones / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D017192:Skin Diseases, Bacterial / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016896:Treatment Outcome; D014640:Vancomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D000081:Acetamides; D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D023303:Oxazolidinones; D014640:Vancomycin; D000069349:Linezolid