A DOUBLE-BLIND COMPARATIVE STUDY ON S 6472 (A LONG ACTING CEFACLOR) VERSUS CONVENTIONAL CEFACLOR PREPARATION IN COMPLICATED URINARY TRACT INFECTIONS

Abstract

For an objective evaluation of the clinical efficacy, safety and usefulness of S 6472 (a long acting cefaclor) in non-catheterized patients with complicated urinary tract infections, a double-blind comparative study was performed using conventional cefaclor preparation (hereafter, CCL) as the control drug.
S 6472 was administered orally at a single dose of 750 mg twice daily, and CCL at a single dose of 500 mg 3 time daily. The duration of the treatment was 5 days for either drug. Clinical efficacies were evaluated according to the criteria for evaluation of drug efficacy by the Japanese UTI Committee (3rd edition), and the following results were obtained.
1. The initial distribution of the patients' background characteristics was not significantly different between the S 6472 and CCL groups.
2. The overall clinical efficacy rates were 76.2% in the S 6472 group and 75.5% in the CCL group, indicating no significant difference between the 2 groups. When clinical efficacies evaluated according to different types of infections (UTI groups), the differences between the 2 drug groups were not significant in any of desease groups 2, 3, 4, and 6.
3. Clinical efficacy rates as evaluated by attending physicians were not significantly different between the 2 groups, either.
4. Bacteriological responses were evaluated as eradicated in 81.2% in the S 6472 group and 78.3% in the CCL group, suggesting no statistically significant difference.
5. The incidences of side effects were 2.9% (4/139) in the S 6472 group and 0.7% (1/141) in the CCL group, thus no significant differences existed between the 2 groups. On laboratory examination, 4 and 5 abnormal test values, respectively, were detected in 3/94 patients in the S 6472 group and 5/100 patients in the CCL group, but the difference wes not significant between the 2 groups, either. All of these side effect symptoms and abnormal laboratory test values were mild in severity and transient. The results of the overall safety rating which was based on the evaluations of the side effects and laboratory test values indicated no significant difference between the 2 groups.
6. According to judgement by the attending doctors, the clinical usefulness rates evaluated based on the results of the efficacy and safety ratings were not significantly different between the S 6472 and CCL groups. These findings suggest that S 6472 produces excellent therapeutic results in complicated noncatheter-indwelt UTI patients and its clinical efficacy, safety, and usefulness are equal to those of the conventional CCL.
Taking into account the advantage of twice-daily dosing for S 6472 instead of 3 times dosing, S 6472 is considered to be a highly useful antibiotics for complicated UTIs.