1994 Volume 42 Issue 10 Pages 1128-1142
An early phase II trial of FK 037, a parenteral cephalosporin, was conducted in patients with respiratory tract infections.
1) The efficacy, safety and usefulness of FK 037 were evaluated in 41 patients with respiratory tract infections who were intravenously infused with the drug at a dose of 0.5, 1.0 or 2.0g, twice daily, for 3 to 14 days, as a rule.
2) Efficacy in 39 patients who were evaluable (26 with pneumonia, 8 with chronic respiratory tract infections, 3 with pyothorax or pleurisy, and 2 with acute bronchitis), was “excellent” in 15 and “good” in 19, an efficacy rate of 87.2%. The efficacy rates by dosage were 91.7%(11/12), 100%(19/19) and 66%(4/6) at 0.5g b. i. d., 1.0g b. i. d. and 2.0g b. i. d., respectively.
3) All of 9 strains of Streptococcus pneumoniae, 7 strains of Haemophilus influenzae and 2 strains of Pseudomonas aeruginosa were eradicated by FK 037 dosing. Of 27 bacterial strains detected, 25 strains (92.6%) were eradicated.
4) No side effects were seen. Abnormal changes in laboratory tests were noted in 12 (30.0%) out of 40 patients who were evaluated for safety. These were mostly mild increases in hepatic enzyme levels, and there were no cases associated with clinical signs or serious cases.
5) The drug was rated “remarkably useful” in 10, of 38 evaluable patients, “useful” in 23, “slightly useful” in 2 and “not useful” in 3, a usefulness rate of 86.8%. These results suggest that FK 037 can be given with good results at clinical doses of 0.5g b. i. d., 1.0g b. i. d. and 2.0g b. i. d.
