title: A controlled, double-blind, multicenter study comparing clarithromycin extended-release tablets and levofloxacin tablets in the treatment of community-acquired pneumonia.
abstract: BACKGROUND
  Macrolides and fluoroquinolones are frequently used for the empiric treatment of community-acquired pneumonia (CAP).
  
  
  OBJECTIVE
  The aim of the study was to compare the safety profile and efficacy of clarithromycin extended-release (ER) tablets with those of levofloxacin tablets for the treatment of CAP in ambulatory adult patients.
  
  
  METHODS
  In a Phase III, double-blind, randomized, parallel-group, multicenter study, ambulatory adult patients (> or = 18 years) with signs and symptoms of CAP received a 7-day course of treatment with either clarithromycin ER (two 500-mg tablets once daily) or levofloxacin (two 250-mg tablets once daily). A diagnosis of CAP was confirmed by radiography of the chest and physical examination, and sputum samples were analyzed to identify etiologic pathogen(s). Tolerability was assessed through subjective reports of adverse events and through changes in physical findings, concomitant medications, and laboratory values.
  
  
  RESULTS
  There were no statistically significant differences between treatment groups in terms of sex, age, race, or body weight. The mean age was 50 years (range, 18-91 years). Of 299 patients randomized and treated, 252 were clinically evaluable (128 clarithromycin ER, 124 levofloxacin). The 95% CI for the difference between cure rates demonstrated equivalence of the 2 treatments. Among clinically evaluable patients at the test-of-cure visit, clinical cure rates were 88% (113/128) and 86% (107/124), and radiographic success rates were 95% (117/123) and 88% (104/118) for clarithromycin ER and levofloxacin, respectively. Both treatment regimens were effective in resolving and improving clinical signs and symptoms of CAP. Among clinically and bacteriologically evaluable pa- tients, bacteriologic cure rates were 86% (80/93) and 88% (85/97) for clarithromycin ER and levofloxacin, respectively. No statistically significant differences were observed between the 2 treatment groups in the overall incidence of adverse events.
  
  
  CONCLUSIONS
  Clarithromycin ER demonstrated equivalent efficacy and tolerability to the fluoroquinolone levofloxacin in a group of ambulatory adult patients with CAP. Clarithromycin ER also appeared to be safe in the population studied.
authors.affiliation: Pulmonary Associates, Phoenix, Arizona 85020, USA. mgotfried@pol.net
authors.forename: Mark H
authors.initials: MH
authors.lastname: Gotfried
authors.forename: Dan
authors.initials: D
authors.lastname: Dattani
authors.forename: Ernie
authors.initials: E
authors.lastname: Riffer
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Devcich
authors.forename: Todd A
authors.initials: TA
authors.lastname: Busman
authors.forename: Gerard F
authors.initials: GF
authors.lastname: Notario
authors.forename: Robert N
authors.initials: RN
authors.lastname: Palmer
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use*; D011014:Pneumonia / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D064704:Levofloxacin; D015242:Ofloxacin; D017291:Clarithromycin