OBJECTIVE: To evaluate the clinical tolerability and efficacy of trovafloxacin compared with sparfloxacin in the treatment of lower respiratory tract infections. DESIGN: This was a randomised, double-blind, controlled, parallel study. PARTICIPANTS AND INTERVENTIONS:92 patients with lower respiratory tract infection were enrolled in three centres. 45 patients received trovafloxacin 200mg once daily orally for 10 days and 43 patients received sparfloxacin 400mg on the first day and 200mg once daily orally for 9 days. Clinical evaluation was performed for fever, dyspnoea, pulmonary symptoms, cough and sputum on days 1, 3, 6 and 12 of the study along with bacteriological evaluation on days 1 and 12. Any adverse effects were also recorded during the study period. RESULTS: There was a significant reduction in the severity of symptoms from day 4 until the end of the study. Clinical cure or improvement was seen in 87 and 95% of the trovafloxacin and sparfloxacin groups, respectively. Bacteriological eradication rates were 84 and 89% for the trovafloxacin and sparfloxacin groups, respectively. The number of adverse effects was 10 and 13 reported by 10 and 13 patients in the trovafloxacin and sparfloxacin groups, respectively. CONCLUSIONS:Trovafloxacin is well tolerated and effective in the treatment of lower respiratory tract infections in a dosage of 200mg daily. It was observed that the efficacy and tolerability of trovafloxacin is comparable to that of sparfloxacin (200mg daily, with a loading dose of 400mg on the first day) in the treatment of lower respiratory tract infections. However, further studies are needed to confirm this.
RCT Entities:
OBJECTIVE: To evaluate the clinical tolerability and efficacy of trovafloxacin compared with sparfloxacin in the treatment of lower respiratory tract infections. DESIGN: This was a randomised, double-blind, controlled, parallel study. PARTICIPANTS AND INTERVENTIONS: 92 patients with lower respiratory tract infection were enrolled in three centres. 45 patients received trovafloxacin 200mg once daily orally for 10 days and 43 patients received sparfloxacin 400mg on the first day and 200mg once daily orally for 9 days. Clinical evaluation was performed for fever, dyspnoea, pulmonary symptoms, cough and sputum on days 1, 3, 6 and 12 of the study along with bacteriological evaluation on days 1 and 12. Any adverse effects were also recorded during the study period. RESULTS: There was a significant reduction in the severity of symptoms from day 4 until the end of the study. Clinical cure or improvement was seen in 87 and 95% of the trovafloxacin and sparfloxacin groups, respectively. Bacteriological eradication rates were 84 and 89% for the trovafloxacin and sparfloxacin groups, respectively. The number of adverse effects was 10 and 13 reported by 10 and 13 patients in the trovafloxacin and sparfloxacin groups, respectively. CONCLUSIONS:Trovafloxacin is well tolerated and effective in the treatment of lower respiratory tract infections in a dosage of 200mg daily. It was observed that the efficacy and tolerability of trovafloxacin is comparable to that of sparfloxacin (200mg daily, with a loading dose of 400mg on the first day) in the treatment of lower respiratory tract infections. However, further studies are needed to confirm this.
Authors: T Miyamoto; J Matsumoto; K Chiba; H Egawa; K Shibamori; A Minamida; Y Nishimura; H Okada; M Kataoka; M Fujita Journal: J Med Chem Date: 1990-06 Impact factor: 7.446
Authors: M Aubier; H Lode; G Gialdroni-Grassi; G Huchon; J Hosie; N Legakis; C Regamey; S Segev; R Vester; W J Wijnands; N Tolstuchow Journal: J Antimicrob Chemother Date: 1996-05 Impact factor: 5.790