Ticarcillin/clavulanate compared with clindamycin/gentamicin (with or without ampicillin) for the treatment of intra-abdominal infections in pediatric and adult patients

Combinations of penicillins with beta-lactamase inhibitors have become acceptable treatments for mixed bacterial infections. The objective of this multicenter, randomized, open-label study was to compare the efficacy, safety, and tolerance of ticarcillin/clavulanate with clindamycin/gentamicin (with or without ampicillin) when administered to adult and pediatric patients with intra-abdominal infections. A total of 993 patients 2 years of age or older were entered in this trial if they had suspected or bacteriologically documented intra-abdominal infection. Of these, 341 were determined at the time of operation to have intra-abdominal infection. Cure rates at the time of final assessment were 79%, 80%, and 82% for ticarcillin/clavulanate, and clindamycin/gentamicin without or with ampicillin, respectively (P = 0.829, Cochran-Mantel-Haenszel). The most frequent reason for failure was development of an intra-abdominal abscess (6% of patients overall), followed by wound infections (4%), and persistent fever (3%). Two patients who had received ticarcillin/clavulanate and five who had received clindamycin/gentamicin required discontinuation of the study regimen because of adverse drug reactions. The bacteria isolated most frequently from study failures were E. coli, B. fragilis, Pseudomonas, and Streptococci. In this study, ticarcillin/clavulanate was as effective as the combination of clindamycin/gentamicin for the treatment of intra-abdominal infections.