Phase II clinical study of pazufloxacin mesilate in complicated urinary tract infection

Abstract

The clinical efficacy, safety, and usefulness of pazufloxacin mesilate, a new parenteral quinolone, in complicated urinary tract infections were evaluated as a phase II study.
As a rule, patients were intravenously infused with 300mg twice daily, or 500mg twice or three times daily, for 5 consecutive days. The following results were obtained.
1. Of the 179 patients infused, 150 were evaluated for clinical efficacy, 164 for safety, and 139 for usefulness, according to the criteria proposed by the Japanese UTI Committee.
2. The overall clinical efficacy rate was 78.7% in all 150 cases, 75.9% in the 58 cases with complicated pyelonephritis, and 80.4% in the 92 cases with complicated cystitis.
3. The overall clinical efficacy rate was 81.6% at the 300mg twice daily dosage, and 77.0% at the 500mg twice daily dosage.
4. The clinical efficacy rate evaluated by doctor was 81.3% in the 150 cases.
5. The overall bacteriological eradication rate was 85.9%, 79.3% for gram-positive bacteria and 91.9% for gram-negative bacteria.
6. Two adverse events were experienced in 179 patients and were mild to moderate in degree. Thirteen events of abnormal changes in laboratory findings were observed in 163 patients and were mild to moderate in degree. The incidence of adverse reactions and abnormal changes in laboratory findings was 1.1% and 8.0%, respectively.
7. From the above findings, we concluded that pazufloxacin mesilate is useful in the treatment of complicated urinary tract infections at the dosages of 600mg to 1500mg daily.