Linezolid for the treatment of children with bacteremia or nosocomial pneumonia caused by resistant gram-positive bacterial pathogens

Pediatr Infect Dis J. 2003 Sep;22(9 Suppl):S164-71. doi: 10.1097/01.inf.0000086956.45566.55.


Background: Nosocomial infections, particularly hospital-acquired pneumonia (HAP) and bacteremia, are an increasing concern in pediatric hospitals and pediatric intensive care units. Gram-positive pathogens are a leading cause of these infections in children. Linezolid is well-tolerated and as effective as vancomycin in the treatment of these infections in adults.

Objective: To evaluate the clinical effectiveness and safety of iv/oral linezolid and iv vancomycin in children with resistant Gram-positive HAP or bacteremia.

Methods: Hospitalized children <12 years of age were randomized 2:1 to linezolid or vancomycin. Patients received 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. Clinical response was evaluated at follow-up. Results from an analysis of patients with HAP or bacteremia are presented.

Results: Thirty-nine patients (linezolid, 23; vancomycin, 16) with HAP and 113 patients with bacteremia (linezolid, 81; vancomycin, 32) were included in the intent-to-treat group. Clinical cure rates for clinically evaluable patients with HAP did not differ between treatment groups (linezolid, 90.0% and vancomycin, 100%; P = 0.305). No significant difference was seen in clinical cure rates in the clinically evaluable population between the linezolid and vancomycin groups for patients with catheter-related bacteremia (84.8 and 80.0%, respectively; P = 0.716) or patients with bacteremia of unknown source (79.2 and 69.2%, respectively; P = 0.501). In this subset fewer linezolid-treated patients had drug-related adverse events than did vancomycin-treated patients (19.4% vs. 28.3%; P = 0.230). Similar percentages of patients with laboratory abnormalities, including selected hematologic parameters, were seen in both treatment groups.

Conclusions: Intravenous/oral linezolid was well-tolerated and as effective as vancomycin in treating children with resistant Gram-positive HAP or bacteremia.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acetamides / administration & dosage
  • Acetamides / adverse effects
  • Acetamides / pharmacology*
  • Administration, Oral
  • Anti-Bacterial Agents / pharmacology*
  • Anti-Infective Agents / administration & dosage
  • Anti-Infective Agents / adverse effects
  • Anti-Infective Agents / pharmacology*
  • Bacteremia / drug therapy*
  • Child
  • Child, Preschool
  • Cross Infection / drug therapy*
  • Drug Resistance, Microbial
  • Female
  • Gram-Positive Bacterial Infections / drug therapy*
  • Humans
  • Infant
  • Infant, Newborn
  • Infusions, Intravenous
  • Linezolid
  • Male
  • Oxazolidinones / administration & dosage
  • Oxazolidinones / adverse effects
  • Oxazolidinones / pharmacology*
  • Pneumonia, Bacterial / drug therapy*
  • Treatment Outcome
  • Vancomycin / pharmacology*


  • Acetamides
  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Oxazolidinones
  • Vancomycin
  • Linezolid