[Clinical results with sulbactam/ampicillin in a multicenter study of 425 patients]

In an open, non-comparative multicenter study, efficacy and toleration of sulbactam/ampicillin for therapy of various infections were investigated. 42 centers in the Federal Republic of Germany and West-Berlin participated in this study. In total, 425 patients were included, 112 of whom suffered from renal/urinary tract infections, 103 from respiratory tract infections, 84 from intraabdominal infections, and 73 from skin/soft tissue infections. Moreover, 43 female patients had gynecological infections. More than 95% of the patients received three daily dosages of 3 g sulbactam/ampicillin via intravenous short-infusion. Mean duration of therapy was 7.3 days. In 280 patients, in total, pathogens were initially identified, among them were 87 patients with mixed infections. At study onset, 393 pathogens were identified, after completion of the trial 63 germs could still be made evident. In 234 cases (= 83.6%) pathogens were eradicated by therapy, in 19 patients superinfection occurred, and in 27 patients pathogenic organisms persisted. 419 patients were included into evaluation of clinical efficacy of sulbactam/ampicillin therapy. In 391 cases (= 93.3%) therapy was successful with 293 patients cured and 98 improved. Therapy failed in 28 patients (= 6.7%) which, in 23 cases, led to discontinuation of treatment. Sulbactam/ampicillin was well tolerated. In total, 55 adverse drug reactions were observed, 22 of which were exanthemas (= 5.2% of all patients). In seven patients (= 1.6%) therapy had to be discontinued due to adverse events. The combination of sulbactam, a beta-lactamase inhibitor, with the reliable antibiotic agent ampicillin has proved to be successful in therapy of infections of different localizations with excellent toleration.