S. Mehtar et al., A MULTICENTER STUDY TO COMPARE MEROPENEM AND CEFOTAXIME AND METRONIDAZOLE IN THE TREATMENT OF HOSPITALIZED-PATIENTS WITH SERIOUS INFECTIONS, Journal of antimicrobial chemotherapy, 39(5), 1997, pp. 631-638
We conducted a prospective, multi-centre, open, randomized study in 11
UK hospitals to compare iv meropenem 1 g tds with the combination of
iv cefotaxime 1 g tds and iv metronidazole 500 mg tds in patients with
serious infections. One hundred and sixty-one patients were enrolled,
of whom 131 were clinically evaluable (meropenem, n = 68; cefotaxime/
metronidazole, n = 63). The most common infections were subsequent to
intra-abdominal pathology (meropenem, n 77%; cefotaxime/metronidazole,
n = 75%), and were usually accompanied by septicaemia (meropenem, n =
61%; cefotaxime/metronidazole, n = 53%). The incidence of a satisfact
ory clinical response was similar in the two groups at the end of trea
tment (93% for meropenem; 92% for cefotaxime/metronidazole) and up to
8 weeks later (96% for meropenem; 93% for cefotaxime/metronidazole). S
atisfactory bacteriological response (success or presumed success) was
recorded at the end of therapy in 86% of meropenem and 88% of cefotax
ime/metronidazole patients. Adverse events were reported in 32% of mer
openem and 25% of cefotaxime/metronidazole patients, and most were mil
d or moderate and did not require discontinuation of therapy, Twenty-o
ne patients (ten meropenem and 11 cefotaxime/metronidazole) died durin
g the trial, underlining the severity of the infections being treated
in this group of patients. None of the deaths was thought to be relate
d to study therapy.