A dose range study on FK 037 in bacterial pneumonia

Abstract

A dose range study on FK 037, a parenteral cephalosporin, was conducted in patients with bacterial pneumonia.
1) Patients with bacterial pneumonia were intravenously infused with FK 037 at a dose of 0.5g (0.5g group), 1.0g (1.0g group) or 2.0g (2.0g group), twice daily, for 14 days as a rule. Of 95 patients, 82 were assessed for the efficacy and clinical usefulness of the drug, and 93 patients for the safety of the drug.
2) The clinical efficacy rate was 85.2%(23/27) in the 0.5 g group, 90.0%(27/30) in the 1.0g group and 92.0%(23/25) in the 2.0g group.
3) In the bacteriological evaluation, the eradication rate was 91.7%(11/12) in the 0.5g group, 85.7%(6/7) in the 1.0g group and 90.9%(10/11) in the 2.0g group.
4) As for side effects, diarrhea was observed in only 1 patient in the 1.0 g group.
5) Abnormal changes in laboratory tests were observed in 6 patients (19.4%) in the0.5g group, 11 patients (34.4%) in the 1.0 g group and 5 patients (17.9%) in the 2.0 g group. None of the abnormal laboratory findings was serious or associated with clinical symptoms.
6) Clinical usefulness rates were 81.5%(22/27), 86.7%(26/30) and 92.0%(23/25) in the 0.5 g, 1.0 g and 2.0 g group, respectively.
We considered that a twice daily dose of 1.0 g of FK 037 is the appropiate clinical dosase for bacterial pneumonia.