TREATMENT OF LOWER RESPIRATORY-TRACT INFECTIONS - WORLDWIDE CLINICAL-TRIALS

A Phase III, open, multicenter study in Europe and Mexico evaluated the efficacy and safety of piperacillin/tazobactam in lower respiratory tract infections; 230 patients were enrolled, 133 patients (58%) were clinically evaluable, and 106 (46%) were bacteriologically evaluable. Diagnoses included pneumonia, bronchitis, bronchopneumonia, pleuropneumonia, and undefined infection. Favorable clinical responses were seen in 97% of patients, with bacterial eradication in 93%. Incidence of adverse experiences was similar to that with other p-lactams. A randomized, double-blind, comparative multicenter study in the United States and Canada enrolled 299 patients. At end point, 39% of 177 patients treated with piperacillin/tazobactam and 41% of 123 patients treated with ticarcillin/clavulanate were evaluable for efficacy. A higher proportion of patients treated with piperacillin/tazobactam had favorable clinical responses in pneumonia (86%) and bronchitis (77%) than did patients treated with ticarcillin/clavulanate for pneumonia (69%) or bronchitis (38%) (P < .01). Piperacillin/tazobactam is effective and safe in the treatment of lower respiratory tract infection and may be superior to ticarcillin/clavulanate.