title: A multicenter, open-label, randomized comparison of levofloxacin and azithromycin plus ceftriaxone in hospitalized adults with moderate to severe community-acquired pneumonia.
abstract: BACKGROUND
  Changing etiologic patterns and the growing problem of antimicrobial resistance, particularly an increase in macrolide-resistant pneumococcal bacteremia, are causing physicians to adopt new approaches to the treatment of community-acquired pneumonia (CAP).
  
  
  OBJECTIVE
  The relative efficacy and tolerability of levofloxacin monotherapy and azithromycin and ceftriaxone combination therapy were assessed in hospitalized adults with moderate to severe CAP.
  
  
  METHODS
  This Phase IV, multicenter, open-label, randomized trial compared 2 treatment regimens: (1) levofloxacin 500 mg PO or IV q24h, and (2) azithromycin 500 mg IV q24h for > or = 2 days plus ceftriaxone 1 g IV q24h for 2 days, followed by an optional transition to azithromycin 500 mg PO q24h at the investigator's discretion. The total duration of therapy was to be a minimum of 10 days in both treatment groups. Ceftriaxone was included in the initial azithromycin regimen to ensure coverage against pneumococcal bacteremia.
  
  
  RESULTS
  Of 236 patients in the intent-to-treat population, completion or withdrawal information was available for 110 patients in the levofloxacin group and 114 in the azithromycin group. Baseline demographic and disease characteristics were comparable between groups. At the end of treatment, the clinical success rate (cured + improved) in clinically evaluable patients was 94.1% in the levofloxacin group and 92.3% in the azithromycin group. The respective posttherapy microbiologic eradication rates were 89.5% and 92.3%. Levofloxacin was as well tolerated as azithromycin, with an incidence of drug-related adverse events (AEs) for all body systems of 5.3% and 9.3%, respectively. None of the drug-related AEs were considered serious [corrected].
  
  
  CONCLUSIONS
  In this study in hospitalized patients with moderate to severe CAP, levofloxacin monotherapy was at least as effective as a combination regimen of azithromycin and ceftriaxone in providing coverage against the current causative pathogens in CAP. In addition, levofloxacin was as well tolerated as the combination of azithromycin and ceftriaxone.
authors.affiliation: Jersey Shore Medical Center, Neptune, New Jersey, USA.
authors.forename: Elliott
authors.initials: E
authors.lastname: Frank
authors.forename: Jing
authors.initials: J
authors.lastname: Liu
authors.forename: Gary
authors.initials: G
authors.lastname: Kinasewitz
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Moran
authors.forename: Margaret P
authors.initials: MP
authors.lastname: Oross
authors.forename: William H
authors.initials: WH
authors.lastname: Olson
authors.forename: Veronica
authors.initials: V
authors.lastname: Reichl
authors.forename: Susan
authors.initials: S
authors.lastname: Freitag
authors.forename: Neelam
authors.initials: N
authors.lastname: Bahal
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Wiesinger
authors.forename: Alan
authors.initials: A
authors.lastname: Tennenberg
authors.forename: James B
authors.initials: JB
authors.lastname: Kahn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017963:Azithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000145:classification / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011014:Pneumonia / Q000145:classification / Q000188:drug therapy*; D012720:Severity of Illness Index
chemical_list: D064704:Levofloxacin; D002443:Ceftriaxone; D017963:Azithromycin; D015242:Ofloxacin