Clinical, bacteriological and pharmacokinetic results from an open trial of sultamicillin in patients with acute exacerbations of chronic bronchitis.

Thirty hospitalised patients with acute purulent exacerbations of chronic bronchitis were treated orally with either 750 or 1000 mg of sultamicillin (a mutual prodrug of ampicillin and sulbactam) twice daily for ten days. Twenty-eight of these patients were evaluated for clinical response at end-of-treatment (day 11) and at one week post-treatment (day 17). The overall clinical cure rates at these times were 73% (22/30) and 60% (18/30) respectively. Five beta-lactamase-producing organisms were identified in the pre-treatment sputum specimens, but all were eliminated by day 17. The means of the peak serum concentrations of ampicillin achieved after the first 750 and 1000 mg doses were 9.1 and 14.4 mg/l respectively, the corresponding values for sulbactam being 6.4 and 7.9 mg/l. Both the ampicillin and the sulbactam peaks occurred approximately one hour after dosage. Mean peak sputum concentrations of ampicillin of 0.7 and 1.2 mg/l were achieved following the 750 and 1000 mg doses. Concentrations of sulbactam in sputum were above the limit of detection (0.5 mg/l) in only four patients. Although both clinical and bacteriological responses at follow-up (day 17) appeared to be somewhat more favourable at the higher dose, the small number of patients in each group did not permit a statistically valid comparison to be made. One patient in each dosage group discontinued the medication because of severe diarrhoea.