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.

DESIGN:

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.

PATIENTS:

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: S L Kaplan, L Patterson, K M Edwards, P H Azimi, J S Bradley, J L Blumer, T Q Tan, F G Lobeck, D C Anderson, Linezolid Pediatric Pheumonia Study Group. Pharmacia and Upjohn
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 20 Issue 5 Pg. 488-94 (May 2001) ISSN: 0891-3668 [Print] United States
• PMID: 11368105 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Acetamides
• Anti-Infective Agents
• Oxazolidinones
• Linezolid

Topics

• Acetamides (administration & dosage, adverse effects, therapeutic use)
• Adolescent
• Anti-Infective Agents (administration & dosage, adverse effects, therapeutic use)
• Child
• Child, Preschool
• Community-Acquired Infections (drug therapy)
• Drug Resistance, Microbial
• Female
• Hospitalization
• Humans
• Infant
• Linezolid
• Male
• Oxazolidinones (administration & dosage, adverse effects, therapeutic use)
• Pneumonia, Bacterial (drug therapy)
• Time Factors