Clinical Trials of Cefotaxime for the Treatment of Bacterial Infections of the Lower Respiratory Tract

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Abstract
The efficacy of cefotaxime sodium for treatment of patients with lower respiratory infections was evaluated by three protocols in multicenter trials. The first trial studied cefotaxime alone; the second and third trials compared cefotaxime with cefazolin in observer-blind and single-blind randomized controlled studies, respectively. A total of 656 patients were entered in the three trials; 527 received cefotaxime. Overall rates of bacteriologic and clinical cure, analyzed by pathogen, for the cefotaxime treated patients were 89.9% and 93.9%, respectively. In the two comparative trials, overall rates of bacteriologic and clinical cure with cefotaxime, by pathogen, were >94% and numerically exceeded those for cefazolin in each instance. The efficacies in the comparative studies, when analyzed by total patient responses, were significantly different only for clinical responses to cefotaxime in the single-blind randomized trial (P = 0.03). Favorable cure rates with cefotaxime were obtained in patients with infections due to Streptococcus pneurnoniae, Haemophilus influenzae, Streptococcus pyogenes, Staphylococcus aureus, and Escherichia coli, and nearly comparable responses were obtained for infections due to Proteus, Enterobacter, and Klebsiella species. Cefotaxime was clinically effective in some of the infections due to Serratia marcescens and Pseudomonas aeruginosa, but bacteriologic failures occurred in 67% and 61% of cases, respectively. All Serratia strains were highly susceptible in vitro to cefotaxime, but the range of minimal inhibitory concentrations of cefotaxime for Pseudomonas isolates was wide.

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