AN OPEN, MULTICENTER CLINICAL-TRIAL OF PIPERACILLIN TAZOBACTAM IN THETREATMENT OF PEDIATRIC-PATIENTS WITH INTRAABDOMINAL INFECTIONS

A total of 60 children with secondary peritonitis were enrolled in an open, non-comparative multicenter study designed to evaluate the safet y, tolerance and efficacy of parenteral piperacillin/tazobactam (80/10 mg/kg every 8 hours) in young children. The most common diagnosis was perforated appendicitis (90%) and the three most common pathogens, ob tained from the peritoneal cavity, were Escherichia coli (52 isolates) , Pseudomonas aeruginosa (16 isolates) and Bacteroides sp. (19 isolate s). Patients were examined daily during therapy, 4-14 days and 4-6 wee ks post-therapy. Of the 60 patients, 43 were evaluable. The majority o f patients had polymicrobial infections (36 patients). All the aerobic isolates were susceptible to piperacillin/tazobactam while 19 were re sistant to piperacillin alone. Four of 43 clinically evaluable patient s were considered a clinical failure and 3 of 40 bacteriologically eva luable patients were considered to have an unfavorable microbiological response. There were 2 clinically adverse events considered related t o the study drug and several possibly related, mild and transitory, ab normalities in eosinophil counts and liver function tests. Based on th e safety and efficacy results from this study, the advantages of using a single agent for the treatment of mixed infections of the peritonea l cavity and its potential activity against resistant. organisms, we b elieve that further comparative clinical trials in children with intra -abdominal infections are warranted.