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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 satisfactory clinical response was similar in the two groups at the end of treatment (93% for meropenem; 92% for cefotaxime/metronidazole) and up to 8 weeks later (96% for meropenem; 93% for cefotaxime/metronidazole). Satisfactory bacteriological response (success or presumed success) was recorded at the end of therapy in 86% of meropenem and 88% of cefotaxime/metronidazole patients. Adverse events were reported in 32% of meropenem and 25% of cefotaxime/metronidazole patients, and most were mild or moderate and did not require discontinuation of therapy. Twenty-one patients (ten meropenem and 11 cefotaxime/metronidazole) died during the trial, underlining the severity of the infections being treated in this group of patients. None of the deaths was thought to be related to study therapy.

A multi-centre study to compare meropenem and cefotaxime and metronidazole in the treatment of hospitalized patients with serious infections