A NONCOMPARATIVE STUDY OF CEFPROZIL AT 2 DOSE LEVELS IN THE TREATMENT OF ACUTE UNCOMPLICATED BACTERIAL SINUSITIS

The efficacy and safety of cefprozil at two dose levels were evaluated in 110 patients with acute uncomplicated bacterial sinusitis in an uncontrolled, noncomparative, Phase II trial. Ninety patients received 250 mg of cefprozil (low-dose group) and 20 patients received 500 mg of cefprozil (high-dose group) every 12 hours for ten days. Evaluable patients had symptoms consistent with acute sinusitis, pathogens isolated at pretreatment susceptible to cefprozil, and a radiograph positive for sinusitis within 48 hours before treatment. A satisfactory clinical response was achieved in 34 of 39 evaluable patients (87%) in the low-dose group and in all 16 evaluable patients (100%) in the high-dose group. Pathogens were eradicated in 35 of 39 patients (90%) in the low-dose group and in 15 of 16 patients (94%) in the high-dose group. A total of 140 of 155 pathogens (90%) isolated pretreatment were susceptible to cefprozil. Six patients (7%) in the low-dose group and one patient (5%) in the high-dose group reported at least one adverse clinical event.