Nosocomial pneumonia: comparative multicentre trial between monotherapy with cefotaxime and treatment with antibiotic combinations

Abstract

In a multicentre clinical trial involving 32 hospitals, 588 adult patients diagnosed with nosocomial pneumonia and not receiving mechanical ventilation were treated randomly with monotherapy with cefotaxime or the antibiotic combination routinely used in each particular hospital. Both groups of patients were similar regarding demographic data, concurrent diseases, additional therapies and causative organism. Protocol violations were recorded in 40 patients, and these patients were excluded from the evaluation of treatment efficacy. The cure rate was 79% in the cefotaxime group and 71% in the group receiving antibiotic combinations; this difference is statistically significant (p = 0.03, Fisher's two-tailed test). In the patients receiving combinations of cephalosporins having activity predominantly against gram-positive organisms plus aminoglycosides, the cure rate obtained was very low. The frequency of serious adverse reactions was significantly higher in the group treated with antibiotic combinations. It is concluded that monotherapy with cefotaxime is the regimen that offers better results for the empirical treatment of nosocomial pneumonia.