Safety and efficacy of temafloxacin versus ciprofloxacin in lower respiratory tract infections: a randomized, double-blind trial.

Temafloxacin, a new fluoroquinolone with broad-spectrum anti-bacterial activity and a favourable pharmacokinetic profile, was evaluated in a prospective, randomized double-blind multicentre study in which 564 patients were enrolled. Ambulatory adults with lower respiratory tract infections were randomly assigned to receive temafloxacin 600 mg or ciprofloxacin 750 mg, each given every 12 h for 7-14 days. Cure or improvement occurred in 93.8% of temafloxacin patients and 93.1% of ciprofloxacin recipients (P greater than 0.05). Bacteriological eradication rates were higher in the temafloxacin group than in the ciprofloxacin group (99.5% vs 92.5%; P = 0.001) primarily because of the failure of ciprofloxacin to eradicate Streptococcus pneumoniae (P = 0.01). Both regimens were well tolerated. In patients who received concomitant theophylline, gastrointestinal and central nervous system disturbances occurred in a higher percentage of patients in the ciprofloxacin group than the temafloxacin group (36.4% vs 9.4%; P less than 0.05). This study indicates that temafloxacin would be suitable for the empirical treatment of lower respiratory tract infections, including high-risk groups such as the elderly and heavy smokers.

RCT Entities:   Population Interventions Outcomes