Abstract |
The relationship between drug exposure and the time course of antimicrobial effect at the primary infection site for acute maxillary sinusitis has not previously been explored. This single-center, open-label study quantified the time course of sinus sterilization, described gatifloxacin exposure at the infection site, and posed the hypothesis that the use of continuous and quantitative time-related end points may allow for better characterization of drug effect with fewer patients than traditional clinical trial approaches. Of the 12 enrolled patients, 10 were clinically evaluable, from whom 7 pathogens were isolated: 4 Streptococcus pneumoniae, 2 staphylococci, and 1 Enterobacter aerogenes. The median predicted 24-h area under the curve (AUC) in sinus aspirates and plasma samples was 54.7 mg x h/L and 30.1 mg x h/L, respectively. The median 24-h AUC ratio for sinus aspirates and plasma samples was 1.51 (range, 0.88-2.23). For patients infected with pneumococci, the median time to sinus sterilization was 50 h. The use of quantitative time-related end points may be useful in evaluating the efficacy of antimicrobial agents with fewer patients.
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Authors | Paul G Ambrose, Jack B Anon, Joel S Owen, Scott Van Wart, Mary Eileen McPhee, Sujata M Bhavnani, Marion Piedmonte, Ronald N Jones |
Journal | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
(Clin Infect Dis)
Vol. 38
Issue 11
Pg. 1513-20
(Jun 01 2004)
ISSN: 1537-6591 [Electronic] United States |
PMID | 15156435
(Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Coagulase
- Fluoroquinolones
- Gatifloxacin
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Topics |
- Acute Disease
- Anti-Bacterial Agents
(adverse effects, pharmacokinetics, pharmacology)
- Coagulase
- Enterobacter aerogenes
(drug effects, isolation & purification)
- Enterobacteriaceae Infections
(diagnosis, drug therapy)
- Female
- Fluoroquinolones
(adverse effects, pharmacokinetics, pharmacology)
- Gatifloxacin
- Humans
- Male
- Maxillary Sinusitis
(drug therapy, microbiology)
- Middle Aged
- Pneumococcal Infections
(diagnosis, drug therapy)
- Staphylococcal Infections
(diagnosis, drug therapy)
- Staphylococcus
(drug effects, isolation & purification)
- Streptococcus pneumoniae
(drug effects, isolation & purification)
- Treatment Outcome
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