Antimicrob Agents Chemother. 1997
Sep;41(9):1965-72.
A multicenter, randomized study
comparing the efficacy and safety of intravenous and/or oral
levofloxacin versus ceftriaxone and/or cefuroxime axetil in
treatment of adults with community-acquired pneumonia.
File TM Jr, Segreti J, Dunbar L, Player R,
Kohler R, Williams RR, Kojak C, Rubin A.
Northeastern Ohio Universities College of Medicine, Rootstown
44272, USA.
Five hundred ninety patients were enrolled
in a prospective, multicenter, randomized trial comparing the
efficacy and safety of 7 to 14 days of levofloxacin treatment
with that of ceftriaxone and/or cefuroxime axetil in the
management of community-acquired pneumonia in adults. Patients
received either intravenous and/or oral levofloxacin (500 mg
once daily) or the comparative agents, parenteral ceftriaxone (1
to 2 g once to twice daily) and/or oral cefuroxime axetil (500
mg twice daily). Erythromycin or doxycycline could be added to
the comparator arm at the investigator's discretion. The
decision to use an intravenous or oral antimicrobial agent for
initial therapy was made by the investigator. Clinical and
microbiological evaluations were completed at the baseline,
during treatment, 5 to 7 days posttherapy, and 3 to 4 weeks
posttherapy. Four hundred fifty-six patients (226 given
levofloxacin and 230 administered ceftriaxone and/or cefuroxime
axetil) were evaluable for clinical efficacy. Streptococcus
pneumoniae and Haemophilus influenzae were isolated in 15 and
12%, respectively, of clinically evaluable patients. One hundred
fifty atypical pathogens were identified: 101 were Chlamydia
pneumoniae, 41 were Mycoplasma pneumoniae, and 8 were Legionella
pneumophila. Clinical success at 5 to 7 days posttherapy was
superior for the levofloxacin group (96%) compared with the
ceftriaxone and/or cefuroxime axetil group (90%) (95% confidence
interval [CI] of -10.7 to -1.3). Among patients with typical
respiratory pathogens who were evaluable for microbiological
efficacy, the overall bacteriologic eradication rates were
superior for levofloxacin (98%) compared with the ceftriaxone
and/or cefuroxime axetil group (85%) (95% CI of -21.6 to -4.8).
Levofloxacin eradicated 100% of the most frequently reported
respiratory pathogens (i.e., H. influenzae and S. pneumoniae)
and provided a >98% clinical success rate in patients with
atypical pathogens. Both levofloxacin and ceftriaxone-cefuroxime
axetil eradicated 100% of the S. pneumoniae cells detected in
blood culture. Drug-related adverse events were reported in 5.8%
of patients receiving levofloxacin and in 8.5% of patients
administered ceftriaxone and/or cefuroxime axetil.
Gastrointestinal and central and peripheral nervous system
adverse events were the most common events reported in each
treatment group. In conclusion, these results demonstrate that
treatment with levofloxacin is superior to ceftriaxone and/or
cefuroxime axetil therapy in the management of
community-acquired pneumonia in adults.
Publication Types: Clinical Trial
Multicenter Study Randomized Controlled Trial
PMID: 9303395 [PubMed - indexed for
MEDLINE]
