S. Snedden et al., Meropenem versus cefotaxime-based therapy for the initial treatment of infants and children hospitalised with non-CNS infections, CLIN DRUG I, 17(1), 1999, pp. 9-20
Objective: This study compared the efficacy and tolerability of meropenem m
onotherapy and cefotaxime-based therapy in infants and children hospitalise
d 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-abd
ominal infection.
Methods: A total of 505 patients from 21 centres throughout the USA were en
rolled. Of these, 253 were randomised to meropenem treatment and 252 to cef
otaxime-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 repor
ted in 98% of meropenem-treated patients and 96% of those treated with cefo
taxime-based therapy. These response rates were sustained at follow-up, irr
espective of the use of additional antibiotic therapy. Meropenem was genera
lly well tolerated. Overall, adverse events occurred with similar frequency
in both treatment arms. No seizures or deaths were reported in either trea
tment group.
Conclusion: Meropenem was well tolerated and effective for the initial empi
rical treatment of children hospitalised with non-CNS infections.