title: Linezolid for the treatment of community-acquired pneumonia in hospitalized children. Linezolid Pediatric Pneumonia Study Group.
abstract: OBJECTIVE
  To determine the safety, tolerance, pharmacokinetics and efficacy of linezolid, a new oxazolidinone antibiotic in the treatment of community-acquired pneumonia in hospitalized children.
  
  
  METHODS
  A Phase II, open label multicenter study of intravenous linezolid followed by oral linezolid suspension, both at a dose of 10 mg/kg every 12 h. Efficacy was assessed at 7 to 14 days after the last dose of linezolid.
  
  
  METHODS
  Children 12 months to 17 years old with community-acquired pneumonia admitted to the hospital of 14 participating centers.
  
  
  RESULTS
  From July 21, 1998, through May 14, 1999, 79 children were enrolled and 78 received linezolid. Sixty-six children completed treatment and follow-up and were evaluable for clinical outcome. The median age of the evaluable patients was 3 years (range, 1 to 12 years); 47 were 2 to 6 years old. Pathogens were isolated from blood or pleural fluid cultures in 8 children: Streptococcus pneumoniae, 6 (2 penicillin-resistant); Group A Streptococcus, 1; methicillin-resistant Staphylococcus aureus, 1. Chest tubes were placed in 9 patients. The mean total duration of intravenous and oral administration was 12.2 +/- 6.2 days (range, 6 to 41 days). The mean peak and trough plasma concentrations of linezolid were 9.5 +/- 4.8 and 0.8 +/- 1.2 microg/ml, respectively. At the follow-up visit 7 to 14 days after the last dose of linezolid, 61 patients (92.4%) were considered cured including all the patients with proven pneumococcal pneumonia, one failed (methicillin-resistant Staphylococcus aureus) and 4 were considered indeterminate. The most common adverse effects in the intent to treat group were diarrhea (10.3%), neutropenia (6.4%) and elevation in alanine aminotransferase (6.4%).
  
  
  CONCLUSIONS
  Linezolid was well-tolerated and could be considered an alternative to vancomycin for treating serious infections caused by antibiotic-resistant Gram-positive cocci in children pending results of additional studies.
authors.affiliation: Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA. skaplan@bcm.tmc.edu
authors.forename: S L
authors.initials: SL
authors.lastname: Kaplan
authors.forename: L
authors.initials: L
authors.lastname: Patterson
authors.forename: K M
authors.initials: KM
authors.lastname: Edwards
authors.forename: P H
authors.initials: PH
authors.lastname: Azimi
authors.forename: J S
authors.initials: JS
authors.lastname: Bradley
authors.forename: J L
authors.initials: JL
authors.lastname: Blumer
authors.forename: T Q
authors.initials: TQ
authors.lastname: Tan
authors.forename: F G
authors.initials: FG
authors.lastname: Lobeck
authors.forename: D C
authors.initials: DC
authors.lastname: Anderson
mesh_terms: D000081:Acetamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004352:Drug Resistance, Microbial; D005260:Female; D006760:Hospitalization; D006801:Humans; D007223:Infant; D000069349:Linezolid; D008297:Male; D023303:Oxazolidinones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D013997:Time Factors
chemical_list: D000081:Acetamides; D000890:Anti-Infective Agents; D023303:Oxazolidinones; D000069349:Linezolid