CLINICAL STUDY ON S 6472 IN URINARY TRACT INFECTION

Abstract

Clinical studies on S 6472, a longer lasting preparation of cefaclor (CCL), were performed and the folowing results were obtained.
S 6472 was administered orally to 102 patients with urinary tract infections including 16 with acute uncomplicated pyelonephritis, 32 with acute uncomplicated cystitis, 31 with complicated pyelonephritis and 23 with complicated cystitis. 95 patients were treated with 375 mg of S 6472 2 times daily and 7 patients were treated with 750 mg of S 6472 2 times daily. The overall clinical efficacy was evaluated on the basis of the criteria proposed by the Japanese UTI Committee.
1. Clinical efficacies in 11 cases of acute uncomplicated pyelonephritis were excellent in 10 and moderate in 1, with an overall efficacy rate of 100%. Bacteriologically, all 12 strains identified in the acute uncomplicated pyelonephiritis cases were eradicated, with an eradication rate of 100%.
2. Clinical efficacies in 21 cases of acute uncomplicated cystitis were excellent in 17, moderate in 3 and poor in 1, with an overall efficacy rate of 95%. As to bacteriological responses, 22 strains identified in the acute uncomplicated cystitis cases (except 1 of Escherichia coli) were eradicated, with an eradication rate of 95%.
3. Clinical responses in 43 cases of complicated urinary tract infections were excellent in 20, moderate in 15 and poor in 8, with an overall efficacy rate of 81%. Bacteriologically, 39 strains, including only one strain of P. aeruginosa, in the complicated urinary tract infection cases (except 4 of E. coli, 1 of Klebsiella pneumoniae, 1 of Enterococcus faecalis and 2 of Enterobacter cloacae) were eradicated, with an eradication rate of 83%.
As side effects, slight stomatitis and gastric discomfort were noted in 1 patient each but we were able to continue the medication. Abnormal laboratory test values found were: 1 case of a slight and transient increase of lymphocytes in peripheral blood and 1 case of a slight and transient increase of serum creatinine level.