title: Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin.
abstract: 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 (i.v.) tigecycline or levofloxacin. Patients could be switched to oral levofloxacin after receiving 6 or more doses of i.v. 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 duration of i.v. or oral antibiotic treatments, hospital readmissions, or number of patients switched to oral levofloxacin. Tigecycline was safe, effective, and noninferior to levofloxacin in hospitalized patients with CAP.
authors.affiliation: Hospital Cordoba, Córdoba, Provincia de Córdoba, Argentina, 5000. infectologiahcba@yahoo.com.ar
authors.forename: Carlos
authors.initials: C
authors.lastname: Bergallo
authors.forename: Abel
authors.initials: A
authors.lastname: Jasovich
authors.forename: Osvaldo
authors.initials: O
authors.lastname: Teglia
authors.forename: Maria Eugenia
authors.initials: ME
authors.lastname: Oliva
authors.forename: Arnold
authors.initials: A
authors.lastname: Lentnek
authors.forename: Luisa
authors.initials: L
authors.lastname: de Wouters
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Zlocowski
authors.forename: Gary
authors.initials: G
authors.lastname: Dukart
authors.forename: Angel
authors.initials: A
authors.lastname: Cooper
authors.forename: Rajiv
authors.initials: R
authors.lastname: Mallick
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006193:Haemophilus influenzae; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D064704:Levofloxacin; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D008911:Minocycline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001936:Moraxella catarrhalis; D015999:Multivariate Analysis; D015242:Ofloxacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D013296:Streptococcus pneumoniae; D000078304:Tigecycline; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D000078304:Tigecycline; D015242:Ofloxacin; D008911:Minocycline