Meropenem versus Cefotaxime-Based Therapy for the Initial Treatment of Infants and Children Hospitalised with Non-CNS Infections

Abstract

Objective: This study compared the efficacy and tolerability of meropenem monotherapy and cefotaxime-based therapy in infants and children hospitalised with non-CNS infections. Patients: Children aged 2 months to 12 years were eligible for enrolment if they had signs and symptoms of respiratory tract infection, urinary tract infection, presumed septicaemia, skin/skin-structure infection or intra-abdominal infection. Methods: A total of 505 patients from 21 centres throughout the USA were enrolled. Of these, 253 were randomised to meropenem treatment and 252 to cefotaxime-based treatment. In all, 205 and 178 patients in the meropenem- and cefotaxime-based treatment groups, respectively, were clinically evaluable. Patients received 2 to 15 days of therapy, and 70% received routine oral antibiotic therapy after parenteral therapy was discontinued. Results: Satisfactory results at the end of parenteral treatment were reported in 98% of meropenem-treated patients and 96% of those treated with cefotaxime-based therapy. These response rates were sustained at follow-up, irrespective of the use of additional antibiotic therapy. Meropenem was generally well tolerated. Overall, adverse events occurred with similar frequency in both treatment arms. No seizures or deaths were reported in either treatment group. Conclusion: Meropenem was well tolerated and effective for the initial empirical treatment of children hospitalised with non-CNS infections.