Prospective, randomized, investigator-blinded study of the efficacy and safety of meropenem vs. cefotaxime therapy in bacterial meningitis in children

Objectives. To compare the efficacy and safety of meropenem with cefotaxime for the treatment of infants and children with bacterial meningitis. Methods, Infants and children with strongly suspected or documented bacteri al meningitis were randomly assigned in a prospective multicenter study to receive either meropenem or cefotaxime, Patients were assessed at the end o f therapy and at 5 to 7 weeks and 5 to 7 months after the end of treatment for the presence of neurologic and sensory neural sequelae, Results. A total of 258 children were randomized to either treatment group. A further 8 patients with suspected pneumococcal meningitis were treated w ith meropenem without randomization. Of the randomized patients 154 were fu lly evaluable, 79 in the meropenem group and 75 in the cefotaxime group. At the end of treatment there were no significant differences in clinical out come between the two treatment groups. Clinical cure with or without sequel ae was achieved in 97 and 96% of the meropenem-and cefotaxime-treated patie nts, respectively. At the end of treatment and at 5 to 7 weeks, 46 and 54% of meropenem patients were cured with no sequelae, respectively. Correspond ing results for cefotaxime patients were 56 and 58%, All pathogens were era dicated. In total 37 patients had seizures during treatment, 15 (12%) in th e meropenem and 22 (17%) in the cefotaxime group. None of the seizures was considered to be drug-related. Conclusions. This trial shows that meropenem is suitable therapy for bacter ial meningitis in infants and children and that it offers an efficacy and s afety profile similar to that of cefotaxime.