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

• Published in: The Pediatric infectious disease journal Vol. 22; no. 9 Suppl; p. S158
• Main Authors: Deville, Jaime G, Adler, Stuart, Azimi, Parvin H, Jantausch, Barbara A, Morfin, Maria Rayo, Beltran, Sandra, Edge-Padbury, Barbara, Naberhuis-Stehouwer, Sharon, Bruss, Jon B
• Format: Journal Article
• Language: English
• Published: United States 01.09.2003
• Subjects: 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
• ISSN: 0891-3668
• DOI: 10.1097/01.inf.0000086955.93702.c7

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