Ciprofloxacin versus cefuroxime axetil in the treatment of adult patients with acute bacterial sinusitis.
OBJECTIVE
This study compared the use and efficacy of ciprofloxacin to cefuroxime axetil for adult patients with acute bacterial sinusitis.


METHODS
We conducted a prospective, randomized, double-blind pilot study of oral ciprofloxacin (500 mg twice daily) versus cefuroxime axetil (250 mg twice daily) for 2 to 3 weeks in the treatment of adult patients with a clinical diagnosis of acute bacterial maxillary sinus infections or acute exacerbation of chronic bacterial sinusitis. Patients with microbiologically and radiologically confirmed sinusitis infection composed the efficacy population.


RESULTS
Of the 83 patients enrolled, 13 of 42 (31%) ciprofloxacin- and 19 of 41 (46%) cefuroxime axetil-treated patients had a respiratory pathogen isolated from a sinus aspiration. The most frequent pretherapy isolated included Haemophilus influenzae (11), streptococcus species (20), staphylococcus species (7), Proteus mirabilis (3), and Neisseria sicca (3). At the end of therapy, clinical resolution or improvement in efficacy-valid patients was achieved in 12 (100%) ciprofloxacin-treated patients and in 14 (74%) cefuroxime axetil recipients. The five (26%) cefuroxime axetil clinical failures were due to development of superinfection. Bacteriologic eradication occurred in 12 (100%) and 14 (100%) ciprofloxacin and cefuroxime axetil patients, respectively. Similar clinical and bacteriologic response rates were observed at the 2- to 4-week follow-up. Among 83 intent-to-treat patients, 19 (45%) ciprofloxacin and 14 (34%) cefuroxime axetil patients had drug-related adverse events. The most common adverse event in both treatment groups was gastrointestinal.


CONCLUSIONS
This pilot study suggests that ciprofloxacin is efficacious in the management of acute bacterial sinusitis.
Klein
G L
GL
San Diego Clinical Research Associates, California, USA.
Whalen
E
E
Echols
R M
RM
Heyd
A
A
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002444:Cefuroxime / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002511:Cephalosporins / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002939:Ciprofloxacin / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011897:Random Allocation; D012852:Sinusitis / Q000188:drug therapy* / Q000382:microbiology
D000890:Anti-Infective Agents; D002511:Cephalosporins; D002939:Ciprofloxacin; D002444:Cefuroxime; C040738:cefuroxime axetil