ORAL EMPIRIC TREATMENT OF COMMUNITY-ACQUIRED PNEUMONIA - A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING SPARFLOXACIN WITH ROXITHROMYCIN

Study objective: Comparison of efficacy and safety of sparfloxacin (Sp fx) vs roxithromycin (ROXI) for treatment of community-acquired pneumo nia (CAP), Design: Multicenter, double-blind, randomized study, Settin g: Twenty-three university and community hospitals in Scandinavia. Pat ients: Three hundred four adults (greater than or equal to 18 years of age) with CAP treated as outpatients (25%) or inpatients(75%). Interv entions: Randomization 1:1 to Spfx, 400 mg on day 1, then 200 mg once daily, or ROXI, 150 mg twice daily; 10 to 14 days. Safety and efficacy analyses in intention-to-treat (ITT) and evaluable populations. Resul ts: Three hundred three of 304 patients were included in the ITT and s afety analyses and 260 (86%) were evaluable at the end of follow-up, S treptococcus pneumoniae was the cause of pneumonia in 62 (20%) patient s (II with bacteremia), Chlamydia pneumoniae in 40 (13%), and Mycoplas ma pneumoniae in 38 (13%) patients, The success rates for Spfx and ROX I at the end of follow-up were 82% and 72%, respectively, in the ITT p opulation, and 94% and 79%, respectively, in the evaluable population, The odds ratio Spfx/ROXI for success was 4.5 (95% confidence interval , 1.9, 10.8) for the evaluable population, Both drugs were, overall, e qually safe, GI symptoms were the most common adverse experiences in b oth groups. Prolongation of QTc, without clinical symptoms, was seen i n 3% of Spfx patients and in 1% of ROXI patients, and photosensitivity , mostly mild to moderate, was seen in 5% of the Spfx group. Conclusio ns: Oral treatment with Spfx was superior to ROXI for the treatment of moderately severe CAP. Spfx was effective for all isolated pathogens, including S pneumoniae, and may be an alternative for empiric treatme nt of CAP, especially in areas with a high incidence of beta-lactam-re sistant pneumococci.