Sparfloxacin for the treatment of acute bacterial maxillary sinusitis documented by sinus puncture.
OBJECTIVE
To evaluate the efficacy and safety of sparfloxacin in the treatment of patients with acute bacterial maxillary sinusitis, the microbiologic etiology of which was determined by maxillary sinus puncture.


METHODS
Two hundred fifty-three patients enrolled in the open, noncomparative trial received sparfloxacin as a 400-mg loading dose followed by 200 mg once daily doses for a total of 10 days. One hundred ninety-eight patients were clinically evaluable and 82 were also bacteriologically evaluable. All treated patients were included in the safety analysis. Overall success was determined based on clinical success (resolution or reduction of signs and symptoms and sinus x-rays) and bacteriologic success (eradication and presumed eradication of baseline pathogens obtained by maxillary sinus puncture and aspiration).


RESULTS
Overall success in the bacteriologically evaluable population at test-of-cure was 91.5% [75/82; 95% confidence interval (85.4%, 97.5%)]. For all pathogens, the eradication rate was 93.2% (109/117 baseline pathogens); individual pathogen eradication rates were 88.9% (16/18) for S. pneumoniae (including those strains exhibiting decreased susceptibility to penicillin); and 100% for H. influenzae (17/17), S. aureus (14/14), and M. catarrhalis (11/11). The majority of adverse events were of mild or moderate severity; the most frequently related adverse events were photosensitivity reaction, headache, nausea, and diarrhea.


CONCLUSIONS
Sparfloxacin had an overall success rate of 91.5% for patients in this study and was generally well tolerated in the treatment of acute bacterial maxillary sinusitis.
Garrison
N
N
Drug Research and Analysis Corporation, Montgomery, Alabama, USA.
Spector
S
S
Buffington
D
D
Stafford
C
C
Granito
K
K
Zhang
H
H
Talbot
G H
GH
D000208:Acute Disease; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D024841:Fluoroquinolones; D005500:Follow-Up Studies; D006801:Humans; D015523:Maxillary Sinusitis / Q000188:drug therapy* / Q000382:microbiology; D011677:Punctures
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; C061363:sparfloxacin