Medline ® Abstract for Reference 89
Safety profile of sparfloxacin in the treatment of respiratory tract infections.
J Antimicrob Chemother. 1996;37 Suppl A:145.
A total of 2081 adult patients with community-acquired lower respiratory tract infections participated in Phase III clinical trials of sparfloxacin. A total of 1040 patients were randomised to sparfloxacin and 1041 patients received a comparator regimen. Sparfloxacin was administered as a 400 mg loading dose on day 1 followed by 200 mg once daily to patients with community-acquired pneumonia and as a 200 mg loading dose on day 1 followed by 100 mg daily to patients with acute exacerbations of chronic obstructive pulmonary disease. Comparator regimens were amoxycillin/clavulanic acid 500/125 mg tid, amoxycillin 1000 mg tid, a combination of amoxycillin 1000 mg tid plus ofloxacin 200 mg bid or erythromycin 1000 mg bid. The incidence of adverse events, the incidence and severity of antibacterial-related adverse events and the incidence of antibacterial discontinuation due to adverse events were no different among patients treated with sparfloxacin compared with those who received a comparator antibacterial agent. Sparfloxacin appears to be as well tolerated as other oral antibacterial regimens commonly used to treat lower respiratory tract infections.
Infectious Diseases Unit, Sheba Medical Center, Tel Aviv University Sackler School of Medicine, Tel-Hashomer, Israel.