Linezolid versus cefadroxil in the treatment of skin and skin structure infections in children.
BACKGROUND
Skin and skin structure infections are common reasons for visits to pediatricians, accounting for up to 18%. Staphylococcus aureus and Streptococcus pyogenes are the most frequently isolated Gram-positive pathogens in uncomplicated skin infections. Increasingly outpatient infections involve antibiotic-resistant Gram-positive pathogens including methicillin-resistant S. aureus.


METHODS
This randomized, blinded, comparator-controlled, multinational trial compared the efficacy and safety of linezolid and cefadroxil for treatment of uncomplicated skin/skin structure infections in pediatric patients. Children ages 5 to 11 years were to receive linezolid suspension [10 mg/kg (up to 600 mg)] or cefadroxil suspension [15 mg/kg (up to 500 mg)] every 12 h. Patients ages 12 to 17 years were to receive linezolid tablets (600 mg) or cefadroxil capsules (500 mg) every 12 h. Therapy lasted 10 to 21 consecutive days with a follow-up visit 10 to 21 days posttherapy.


RESULTS
Linezolid and cefadroxil were consistently effective treatments across all primary and secondary efficacy assessments. At follow-up cure rates were 88.7% (205 of 231) for linezolid-treated and 86.2% (193 of 224) for cefadroxil-treated intent-to-treat patients; cure rates were 91.0% (201 of 221) for linezolid-treated and 90.0% (189 of 210) for cefadroxil-treated clinically evaluable patients. S. aureus was eradicated in 89.6% (120 of 134) linezolid-treated and 88.8% (111 of 125) cefadroxil-treated microbiologically evaluable patients. Gastrointestinal complaints were the most common adverse events reported, without significant differences between treatment groups, and myelosuppression was not observed in this study.


CONCLUSIONS
Linezolid is well-tolerated and as effective as cefadroxil in treating uncomplicated skin infections in pediatric patients. Linezolid effectively treated infections caused by S. aureus, methicillin-resistant S. aureus and S. pyogenes.
Wible
Kenneth
K
Children's Mercy Hospital, Kansas City, Missouri, USA.
Tregnaghi
Miguel
M
Bruss
Jon
J
Fleishaker
Dona
D
Naberhuis-Stehouwer
Sharon
S
Hilty
Milo
M
D000081:Acetamides / Q000008:administration & dosage*; D000284:Administration, Oral; D000293:Adolescent; D002434:Cefadroxil / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D016908:Gram-Positive Bacterial Infections / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D000069349:Linezolid; D008297:Male; D023303:Oxazolidinones / Q000008:administration & dosage*; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D016037:Single-Blind Method; D012874:Skin Diseases, Infectious / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
D000081:Acetamides; D023303:Oxazolidinones; D002434:Cefadroxil; D000069349:Linezolid