Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin

Tigecycline exhibits potent in vitro activity against many community-acquired pneumonia (CAP) pathogens, including antibiotic-resistant ones. Its spectrum of activity and ability to penetrate lung tissue suggest it may be effective for hospitalized CAP patients. Hospitalized CAP patients (n = 418) were randomized to receive intravenous (IV) tigecycline or levofloxacin. Patients could be switched to oral levofloxacin after receiving 6 or more closes of IV study medication. Therapy duration was 7 to 14 days. Coprimary efficacy end points were clinical responses in the clinically evaluable (CE: tigecycline, n = 138; levofloxacin, n = 156) and clinical modified intent-to-treat (c-mITT: tigecycline, n = 191; levofloxacin, n = 203) populations at test-of-cure (TOC). Safety was assessed in the mITT population (tigecycline, n = 208; levofloxacin, n = 210). Cure rates in tigecycline and levofloxacin groups were comparable in CE (90.6% versus 87.2%, respectively) and c-mITT (78% versus 77.8%, respectively) populations at TOC. Nausea and vomiting occurred in significantly more tigecycline-treated patients, elevated alanine aminotransferase and aspartate aminotransferase levels were reported in significantly more levofloxacin-treated patients. There were no significant differences in hospital length of stay, median