Linezolid versus vancomycin in the treatment of known or suspected resistant gram-positive infections in neonates

Pediatr Infect Dis J. 2003 Sep;22(9 Suppl):S158-63. doi: 10.1097/01.inf.0000086955.93702.c7.

Abstract

Background: Gram-positive infections caused by susceptible and resistant strains of Staphylococcus aureus, coagulase-negative staphylococci and enterococci are increasing problems in neonates. Linezolid, a new oxazolidinone, is active against these pathogens and has recently been approved by the Food and Drug Administration for treating Gram-positive infections in pediatric patients.

Objective: To compare the clinical efficacy and safety of intravenous and oral linezolid with vancomycin (10 to 15 mg/kg every 6 to 24 h) in neonates (age 0 to 90 days).

Methods: Hospitalized infants with known or suspected hospital-acquired pneumonia, complicated skin or skin structure infections, bacteremia or other infections (e.g. pyelonephritis, abdominal abscess) were eligible. Test-of-cure clinical response was evaluated at follow-up.

Results: Sixty-three neonates, randomized 2:1 to linezolid (n = 43) or vancomycin (n = 20) were included in the intent-to-treat group. Clinical cure rates at follow-up in the intent-to-treat group were higher, but not significantly different, for linezolid vs. vancomycin (78% vs. 61%; P = 0.196). Corresponding cure rates in clinically evaluable patients were 84% vs. 77% (P = 0.553) for linezolid and vancomycin, respectively. Pathogen eradication rates were as follows in the linezolid and vancomycin groups, respectively: S. aureus (67% vs. 60%; P = 0.850); coagulase-negative staphylococci (88% vs. 100%; P = 0.379); and enterococci (71% vs. 0%; P = 0.168). Results for hematology and chemistry assays were similar between treatment groups. Fewer linezolid-treated neonates had drug-related adverse events than vancomycin-treated neonates (12% vs. 32%; P = 0.058).

Conclusions: Linezolid is well-tolerated and as effective as vancomycin in the treatment of resistant Gram-positive infections in neonates.

Publication types

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

MeSH terms

  • Acetamides / administration & dosage
  • Acetamides / adverse effects
  • Acetamides / pharmacology*
  • Administration, Oral
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / pharmacology*
  • Anti-Infective Agents / administration & dosage
  • Anti-Infective Agents / adverse effects
  • Anti-Infective Agents / pharmacology*
  • Female
  • Gram-Positive Bacterial Infections / drug therapy*
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Newborn, Diseases / drug therapy
  • Infusions, Intravenous
  • Linezolid
  • Male
  • Oxazolidinones / administration & dosage
  • Oxazolidinones / adverse effects
  • Oxazolidinones / pharmacology*
  • Treatment Outcome
  • Vancomycin / adverse effects
  • Vancomycin / pharmacology*

Substances

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