Linezolid versus vancomycin for treatment of resistant Gram-positive infections in children.
BACKGROUND
Pediatric infections caused by resistant Gram-positive infections are an increasing concern with limited treatment options. Linezolid, a new oxazolidinone, is active against staphylococci, streptococci and enterococci.


OBJECTIVE
To assess clinical efficacy and safety of linezolid vs.vancomycin in antibiotic-resistant Gram-positive infections in children. DESIGN Hospitalized children (birth to 12 years of age) with nosocomial pneumonia, complicated skin/skin structure infections, catheter-related bacteremia, bacteremia of unknown source or other infections caused by Gram-positive bacteria were randomized 2:1 to receive linezolid intravenously followed by oral linezolid or vancomycin and then by an appropriate oral agent. Treatment duration was 10 to 28 days.


RESULTS
There were 321 patients enrolled (linezolid 219, vancomycin 102). Clinical cure rates were 79% vs.74% (P = 0.36) and 89% vs.85% (P = 0.31) for linezolid and vancomycin in intent-to-treat and clinically evaluable patients, respectively. Cure rates were similar by age and infection diagnosis. Pathogen eradication rates in microbiologically evaluable patients were high for linezolid and vancomycin, respectively, for methicillin-susceptible S. aureus (95% vs.94%; P = 0.82), methicillin-resistant S. aureus (88% vs.90%; P = 0.89) and methicillin-resistant coagulase-negative staphylococci (85% vs.83%, P = 0.87). In clinically evaluable patients, linezolid-treated patients required significantly fewer days of intravenous therapy compared with vancomycin-treated patients (8.0 +/- 4.8; 10.9 +/- 5.8 days, respectively; P < 0.001). In addition significantly fewer linezolid-treated patients had drug-related adverse events than did vancomycin-treated patients (19% vs.34%, respectively; P = 0.003). Hematologic events were uncommon and similar between treatment groups.


CONCLUSIONS
Linezolid was well-tolerated and as effective as vancomycin in treating serious Gram-positive infections in children.
Kaplan
Sheldon L
SL
Baylor College of Medicine and Texas Children's Hospital, 6621 Fannin Street, MC3-2371, Feigin Center No. 1150, Houston, TX 77030, USA. Skaplan@bcm.tmc.edu
Deville
Jaime G
JG
Yogev
Ram
R
Morfin
Ma Rayo
MR
Wu
Elba
E
Adler
Stuart
S
Edge-Padbury
Barbara
B
Naberhuis-Stehouwer
Sharon
S
Bruss
Jon B
JB
D000081:Acetamides / Q000008:administration & dosage*; D016470:Bacteremia / Q000175:diagnosis / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D003428:Cross Infection / Q000175:diagnosis / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D018432:Drug Resistance, Multiple; D005260:Female; D005500:Follow-Up Studies; D006094:Gram-Positive Bacteria / Q000145:classification / Q000187:drug effects*; D016908:Gram-Positive Bacterial Infections / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007843:Latin America; D000069349:Linezolid; D008297:Male; D008826:Microbial Sensitivity Tests; D023303:Oxazolidinones / Q000008:administration & dosage*; D011336:Probability; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States; D014640:Vancomycin / Q000008:administration & dosage*
D000081:Acetamides; D023303:Oxazolidinones; D014640:Vancomycin; D000069349:Linezolid