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Home » FULL RESULTS RELEASED FROM OSCIENT'S ANTIBIOTIC STUDY
FULL RESULTS RELEASED FROM OSCIENT'S ANTIBIOTIC STUDY
September 19, 2005
Data from a study of Oscient Pharmaceuticals' fluoroquinolone antibiotic, Factive (gemifloxacin mesylate) tablets, for the potential five-day treatment of mild-to-moderate community-acquired pneumonia (CAP) is being presented at the Second International Conference on Community-Acquired Pneumonia in Montreal, Canada.
The multicenter, double-blind study enrolled 510 patients with CAP, with 468 patients comprising the per protocol group. Investigators measured clinical and bacteriological response at end of therapy as well as clinical, bacteriological and radiologic response at follow-up (two to three weeks post-therapy). Clinical response at follow-up, the primary endpoint, in the per protocol group was 95 percent for the five-day treatment arm and 92 percent for the seven-day treatment arm, demonstrating noninferiority between the two groups. Further, clinical response at end of therapy in the per protocol group was 96 percent for the five-day group and 96 percent for the seven-day group. Factive was well-tolerated in the study, with a low withdrawal rate due to adverse events.
KEYWORDS Drug Pipeline Alert
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