[An open comparative study of sulbactam/ampicillin vs mezlocillin in adult and pediatric patients. Efficacy and tolerability]

Abstract

Sulbactam is a beta-lactamase inhibitor that, when combined with ampicillin, extends its antibacterial activity against beta-lactamases producing organisms. The clinical efficacy and safety of the sulbactam/ampicillin (S/A) combination versus mezlocillin (M), was assessed in a prospective comparative randomised study. Sixty-five patients (12 children), with lower respiratory tract infections (40), UTIs (20), and skin/soft tissue infections (5), were treated with S/A (32) or M (33 patients), given IV or IM. The two treatment groups did not significantly differ in types of infection, infecting organisms, and severity of underlying disease. Explicit criteria were used to define infections, clinical response, local and systemic tolerability, and adverse effects. A total of 33 organisms were isolated; 3/33 were resistant to S/A, 7/33 to M, and 15/33 to A alone. A successful clinical outcome (cure + improvement), was obtained in 29 out of 30 assessable patients in the S/A group, and in 30/31 in the M group. Both treatments resulted 100% effective in eradicating infecting pathogens: this confirms their high bactericidal activity, also against bacterial species showing remarkable antibiotic resistance patterns, and in variously immunocompromised hosts. Both S/A and M; therapeutic courses were well tolerated; only four out of the 61 assessable patients (2 in S/A, and 2 in M group), experimented mild, transient side-effects, that did not require modification of the treatment regimens. We conclude that both S/A and M appeared very safe and effective drugs; in regard to clinical and microbiological effectiveness and local and systemic tolerability, no statistically significant differences (p greater than 0.05) between the two groups were observed, in treating various bacterial infections, in both adult and paediatric age.