Prospective, randomized, investigator-blinded study of the efficacy and safety of meropenem vs. cefotaxime therapy in bacterial meningitis in children. Meropenem Meningitis Study Group.
OBJECTIVE
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 bacterial meningitis were randomly assigned in a prospective multicenter study to receive either meropenem or cefotaxime. Patients were assessed at the end of 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 with meropenem without randomization. Of the randomized patients 154 were fully evaluable, 79 in the meropenem group and 75 in the cefotaxime group. At the end of treatment there were no significant differences in clinical outcome between the two treatment groups. Clinical cure with or without sequelae was achieved in 97 and 96% of the meropenem- and cefotaxime-treated patients, respectively. At the end of treatment and at 5 to 7 weeks, 46 and 54% of meropenem patients were cured with no sequelae, respectively. Corresponding results for cefotaxime patients were 56 and 58%. All pathogens were eradicated. In total 37 patients had seizures during treatment, 15 (12%) in the 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 bacterial meningitis in infants and children and that it offers an efficacy and safety profile similar to that of cefotaxime.
Odio
C M
CM
Children's Hospital and Health Science Center, School of Medicine, Universidad Autónoma de Centro América, San José, Costa Rica. codio@hnn.sa.cr
Puig
J R
JR
Feris
J M
JM
Khan
W N
WN
Rodriguez
W J
WJ
McCracken
G H
GH
Bradley
J S
JS
D002439:Cefotaxime / Q000009:adverse effects / Q000627:therapeutic use*; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D016920:Meningitis, Bacterial / Q000188:drug therapy*; D000077731:Meropenem; D011446:Prospective Studies; D016037:Single-Blind Method; D013845:Thienamycins / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D002511:Cephalosporins; D013845:Thienamycins; D000077731:Meropenem; D002439:Cefotaxime