Linezolid for the treatment of community-acquired pneumonia in hospitalized children

Objective, To determine the safety, tolerance, pharmacokinetics and efficac y of linezolid, a new oxazolidinone antibiotic in the treatment of communit y-acquired pneumonia in hospitalized children, Design. A Phase II, open label multicenter study of intravenous linezolid f ollowed 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. Patients. Children 12 months to 17 years old with community-acquired pneumo nia admitted to the hospital of 14 participating centers. Results. From July 21, 1998, through May 14, 1999, 79 children were enrolle d and 78 received linezolid, Sixty-six children completed treatment and fol low-up and were evaluable for clinical outcome. The median age of the evalu able 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 Streptococc us, 1; methicillin-resistant Staphylococcus aureus, 1. Chest tubes were pla ced in 9 patients. The mean total duration of intravenous and oral administ ration was 12.2 +/- 6.2 days (range, 6 to 41 days). The mean peak and troug h plasma concentrations of linezolid were 9.5 +/- 4.8 and 0.8 +/- 1.2 mug/m l, 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 pat ients with proven pneumococcal pneumonia, one failed (methicillin-resistant Staphylococcus aureus) and 4 were considered indeterminate. The most commo n adverse effects in the intent to treat group were diarrhea (10.3%), neutr openia (6.4%) and elevation in alanine aminotransferase (6.4%). Conclusions. Linezolid was well-tolerated and could be considered an altern ative to vancomycin for treating serious infections caused by antibiotic-re sistant Gram-positive cocci in children pending results of additional studi es.