A double-blind study of once-daily temafloxacin in the treatment of bacterial lower respiratory tract infections.

The safety and efficacy of a seven to 14 day course of temafloxacin 600 mg once daily were compared to ciprofloxacin 500 mg bd in adult patients with bacterial infections of the lower respiratory tract in a multicentre, double-blind, randomized clinical trial. Patients were enrolled if they had symptoms and signs of infection consistent with acute exacerbation of chronic bronchitis or uncomplicated pneumonia, confirmed by X-ray. Clinical and bacteriological evaluations were performed within 48 h before enrollment, during treatment (study day 2 to 5), 1-3 days post-treatment, and 5-9 days post-treatment. Interim results are reported. Temafloxacin produced a similar clinical success to ciprofloxacin, 98% (114 of 116) and 97% (117 of 121) of patients respectively; all treated patients with pneumococcal infection except one who received ciprofloxacin were clinical successes. Temafloxacin resulted in earlier bacteriological response, especially apparent after the second and third day of therapy and among smokers and the elderly (greater than or equal to 65 years old). Five to nine days after stopping treatment 98% of pretreatment pathogens were eradicated: 124/126 and 132/135 in the temafloxacin and ciprofloxacin groups respectively. Adverse reactions occurred among 8.6% (12 of 140) of temafloxacin treated patients compared to 5.8% (8 of 138) of ciprofloxacin treated patients. All adverse events reported were of mild to moderate severity and no patients withdrew from the study prematurely due to these events. The preliminary results from this study suggest that once daily temafloxacin gives high rates of clinical and bacteriological success, similar to twice daily ciprofloxacin, in the management of bacterial infections in the lower respiratory tract.