TEMAFLOXACIN COMPARED WITH CIPROFLOXACIN IN MILD TO MODERATE LOWER RESPIRATORY-TRACT INFECTIONS IN AMBULATORY PATIENTS - A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY

The efficacy and safety of oral temafloxacin (600 mg) and ciprofloxacin (500 mg) twice daily for seven days were compared in patients with mild to moderate lower respiratory tract infections. Fifty-eight of 64 (91 percent) patients who received temafloxacin and 63 of 67 (94 percent) patients who received ciprofloxacin had clinical cure or improvement; bacteriologic cure occurred in 61 (95 percent) and 63 (94 percent), respectively. All 14 patients with pneumonia were clinically cured or improved and bacteriologically cured; 11 had complete resolution of roentgenographic evidence of pneumonia. Both quinolones eradicated most major respiratory pathogens. In the ciprofloxacin group, organisms persisted in three of seven Pseudomonas aeruginosa isolates and in one of eight Hemophilus parainfluenzae isolates; all these pathogens were eliminated with temafloxacin. Theophylline blood levels significantly increased by 25 percent in the ciprofloxacin group and decreased by 5 percent in the temafloxacin group. Adverse events, mostly dizziness, headache, and gastrointestinal effects, occurred in 43 percent of temafloxacin patients and in 31 percent of ciprofloxacin patients.