RESULTS OF THE NORTH-AMERICAN TRIAL OF PIPERACILLIN TAZOBACTAM COMPARED WITH CLINDAMYCIN AND GENTAMICIN IN THE TREATMENT OF SEVERE INTRAABDOMINAL INFECTIONS/

A total of 192 men and 139 women aged 15 to 89 years with diagnosed in tra-abdominal infection were randomised in a 2:1 ratio to treatment wi th either intravenous piperacillin/tazobactam (3 g/375 mg every six ho urs) or clindamycin (600 mg every six hours) plus gentamicin (2.5 mg t o 5.0 mg/kg every eight to 12 hours) in a multicentre trial. Of 147 ev aluable patients with microbiologically confirmed infections, 104 were treated with piperacillin/tazobactam and 43 with clindamycin plus gen tamicin. The diagnoses of perforated appendicitis (n = 79), other peri tonitis (n = 32), cholecystitis/cholangitis (n = is), intraabdominal a bscess (n = 14), and diverticulitis (n = 3), were distributed proporti onately between the two therapeutic groups. Ninety one of 104 patients (88%) in the piperacillin/tazobactam group and 33 of 43 patients (77% ) in the clindamycin plus gentamicin group were considered cured or im proved (p = 0.13). In the piperacillin/tazobactam group, 80 of 88 (91% ) Bacteroides fragilis group organisms and 68 of 74 (92%) E coli isola tes were eradicated; in the clindamycin plus gentamicin group, 21 of 2 5 (84%) Bacteroides fragilis group isolates and 23 of 30 (76%) E coil isolates were eradicated. Eleven evaluable patients in the piperacilli n/tazobactam group had beta-lactamase-producing organisms that were re sistant to piperacillin but susceptible to piperacillin/tazobactam; in 10 of these patients (91%) bacteria were eradicated. We conclude that piperacillin/tazobactam is an effective antimicrobial drug for monoth erapy of intra-abdominal infections, with efficacy similar to or bette r than standard aminoglycoside/anti-anaerobe combinations.