Clinical evaluation of sulbactam plus ampicillin in the treatment of general pediatric infections

Abstract

Sixty pediatric patients (27 males and 33 females) between the ages of 7 months and 11.7 years (mean age = 4.3 yr) were treated with parenteral sulbactam plus ampicillin (1:2 ratio) for lower respiratory tract infections (29 cases), upper respiratory tract infections (4 cases), urinary tract infections (25 cases) or skin/soft tissue infections (2 cases). The infection was mild in 6 cases, moderate in 44 and severe in 10. The infection was acute in 57 patients, recurrent in 1 (cystitis) and was a flare-up of a chronic infection in 2 (pyelonephritis and cystitis). The children received an average dose of 48 mg/kg/d of sulbactam plus 96 mg/kg/d of ampicillin by the i.m. route (43 cases) or by i.v. drip (17 cases) in 3-4 divided doses. The length of treatment ranged between 3 and 10 d (mean duration = 6 d). At the end of therapy, clinical cure was achieved in 53 patients (88.3%), while 6 (10%) had a marked improvement. Only 1 patient, with a lower respiratory tract infection, did not respond to therapy. All 25 patients with urinary tract infection experienced bacteriological cure at the end of treatment. No side effects were reported. Mild and transient changes in laboratory parameters from baseline values were observed in 10 patients (eosinophilia, elevation of SGOT or SGPT) without clinical consequence. Sulbactam plus ampicillin was effective and safe in the treatment of bacterial infections in children and appears to be useful in the treatment of those infections in which beta-lactamase-producing organisms are involved.