Clinical evaluation of sulbactam/ampicillin in Japan.

A total of 754 patients were treated intravenously with sulbactam/ampicillin, in a clinical trial to determine the efficacy and safety of the drug. The majority of patients were treated with 3 g/day by intravenous infusion for 4 to 14 days. Clinical response was evaluated in 689 of 754 patients. In the treatment of respiratory and urinary tract infections, efficacy was 82.5% and 77.1%, respectively. Overall, sulbactam/ampicillin was effective in 80.4% of all evaluable patients. Of 175 patients who failed to respond to prior antibiotic therapy, 135 patients (77.1%) were effectively treated with sulbactam/ampicillin. The overall bacteriological eradication rate was 91.8% against Gram-positive organisms, 75.9% against Gram-negative organisms, and 90% against anaerobes. In addition, 166 of 221 strains that were beta-lactamase producers were eradicated after treatment with sulbactam/ampicillin. Side effects such as rash, fever, itching, urticaria, and diarrhea occurred in only 2.65%, 20 of 754 cases. Laboratory abnormalities were similar to those reported for other beta-lactam antibiotics, including increases in levels of SGOT (4.9%), SGPT (5.7%), and eosinophilia (3.4%) counts. The study showed that sulbactam/ampicillin has a broad spectrum of antibacterial activity against both Gram-positive and Gram-negative organisms as well as anaerobes. There was a high degree of safety. Thus, sulbactam/ampicillin is effective and safe as a treatment for medical, surgical, urological, and gynecological infections.