Efficacy and safety of ampicillin/sulbactam and cefuroxime in the treatment of serious skin and skin structure infections in pediatric patients

Background. Pediatric skin and skin structure infections are often polymicr obial and require empiric therapy effective against pathogens that may be r esistant to many antimicrobial agents. The present study tested the efficac y and safety of a parenteral beta-lactam/beta-lactamase inhibitor combinati on, ampicillin/sulbactam, and a beta-lactamase-stable cephalosporin, cefuro xime, in serious pediatric skin and skin structure infections requiring hos pitalization and parenteral antimicrobial therapy, Methods, This was a multicenter, randomized, prospective, comparative open label trial that enrolled patients 3 months through 11 years of age, Patien ts received 150 to 300 mg/kg/day ampicillin/sulbactam in equally divided in travenous doses every 6 h, Cefuroxime was given in a dosage of 50 to 100 mg /kg/day either intravenously or intramuscularly in equally divided doses ev ery 6 or 8 h, Maximum treatment was not to exceed 14 days, Patients could r eceive subsequent oral antimicrobial treatment at the investigator's discre tion. Results. At final evaluation for clinical efficacy, 78.0% (n = 46) of the 5 9 evaluable patients who received ampicillin/sulbactam were cured and 22.0% (n = 13) were improved. The respective values for the 39 evaluable patient s treated with cefuroxime were 76.9% (n = 30) and 23.1% (n = 9), At the end of treatment all pathogens were eradicated from 93.2% (n = 55) of 59 patie nts treated with ampicillin/sulbactam and from 100% of 39 who received cefu roxime, There were no significant differences between treatments in clinica l or bacteriologic efficacy. Both ampicillin/sulbactam and cefuroxime were well-tolerated, Conclusion, Both ampicillin/sulbactam and cefuroxime provide safe and effec tive parenteral antibiotic therapy in pediatric patients with serious skin and skin structure infections.