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Linezolid versus vancomycin for treatment of resistant Gram-positive infections in children.
Pediatr Infect Dis J 2003; 22(8):677-86PI

Abstract

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.

Authors+Show Affiliations

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.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12913766

Citation

Kaplan, Sheldon L., et al. "Linezolid Versus Vancomycin for Treatment of Resistant Gram-positive Infections in Children." The Pediatric Infectious Disease Journal, vol. 22, no. 8, 2003, pp. 677-86.
Kaplan SL, Deville JG, Yogev R, et al. Linezolid versus vancomycin for treatment of resistant Gram-positive infections in children. Pediatr Infect Dis J. 2003;22(8):677-86.
Kaplan, S. L., Deville, J. G., Yogev, R., Morfin, M. R., Wu, E., Adler, S., ... Bruss, J. B. (2003). Linezolid versus vancomycin for treatment of resistant Gram-positive infections in children. The Pediatric Infectious Disease Journal, 22(8), pp. 677-86.
Kaplan SL, et al. Linezolid Versus Vancomycin for Treatment of Resistant Gram-positive Infections in Children. Pediatr Infect Dis J. 2003;22(8):677-86. PubMed PMID: 12913766.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Linezolid versus vancomycin for treatment of resistant Gram-positive infections in children. AU - Kaplan,Sheldon L, AU - Deville,Jaime G, AU - Yogev,Ram, AU - Morfin,Ma Rayo, AU - Wu,Elba, AU - Adler,Stuart, AU - Edge-Padbury,Barbara, AU - Naberhuis-Stehouwer,Sharon, AU - Bruss,Jon B, AU - ,, PY - 2003/8/13/pubmed PY - 2003/9/27/medline PY - 2003/8/13/entrez SP - 677 EP - 86 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 22 IS - 8 N2 - 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. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/12913766/Linezolid_versus_vancomycin_for_treatment_of_resistant_Gram_positive_infections_in_children_ L2 - http://dx.doi.org/10.1097/01.inf.0000078160.29072.42 DB - PRIME DP - Unbound Medicine ER -