Two hundred and seventy-six hospitalized patients with severe
infection (complicated UTI,
pneumonia, skin and
soft tissue infection or septicaemia) were randomly allocated to receive either 1g or 2g
cefpirome bd. Two hundred and seventy-four patients were evaluable for tolerance, 210 for bacteriological efficacy. The two groups were similar in terms of underlying disease, age, sex, and general condition on admission. The overall clinical and bacteriological response rates were 97/103 (94%) and 68/76 (90%) respectively in the 1g group, compared with 102/107 (95%) and 67/71 (94%) in the 2g group. There was no significant difference between the treatment groups. Eighteen adverse events, possibly or probably
drug related, were reported (7 in the 1g group, 11 in the 2g group). This resulted in discontinuation of
therapy in four cases (two in each group). Fourteen of the adverse events were local (five receiving 1g, nine receiving 2g), mainly
phlebitis or
pain at the injection site. Thirteen patients died during the study period (up to 14 days after the last dose) but in no case was death attributed to
cefpirome. A review of routine laboratory parameters revealed no abnormalities which could definitely be attributed to
cefpirome although in four cases a relationship was considered possible; these included two increases in serum
creatinine, one increase in
SGPT, and one episode of
neutropenia.
Cefpirome administered as 1 or 2g twice daily was a well tolerated, effective agent for the treatment of
severe sepsis in hospitalized patients.