Pharmacokinetics and pharmacodynamics of gatifloxacin in children with recurrent otitis media:: application of sparse sampling in clinical development

被引:3
|
作者
Rubino, Christopher M. [1 ]
Ambrose, Paul
Cirincione, Brenda
Arguedas, Adriano
Sher, Lawrence
Lopez, Eduardo
Saez-Llorens, Xavier
Grasela, Dennis M.
机构
[1] Ordway Res Inst, Inst Clin Pharmacodynam, Albany, NY 12206 USA
[2] Cognigen Corp, Buffalo, NY 14221 USA
[3] Univ Calif Los Angeles, Rolling Hills Estates, CA 90274 USA
[4] Hosp Nino, Program Infect Dis, Buenos Aires, DF, Argentina
[5] Hosp Nino, Dept Infect Dis, El Dorado, Panama
[6] Bristol Myers Squibb Co, Pharmaceut Res Inst, Dept Clin Pharmacol Expt Med, Princeton, NJ 08543 USA
关键词
gatifloxacin; otitis media; pharmacokinetics; pharmacodynamics;
D O I
10.1016/j.diagmicrobio.2007.04.015
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Gatifloxacin is a 4th-generation fluoroquinolone previously under investigation for the treatment of otitis media in infants and children. These analyses were designed to evaluate the extent of drug exposure relative to adult populations and to examine the relationship between drug exposure and response to therapy in children with recurrent otitis media or early treatment failures of acute otitis media. The patient population included 187 patients from an open-label, multicenter, noncomparative study using gatifloxacin 10 mg/kg once daily. Gatifloxacin exposure was estimated using a single steady-state blood sample in conjunction with a pharmacostatistical model developed using a separate pediatric data set. Gatifloxacin exposure was equivalent to that in adults given 400 mg daily. Of the 41 patients who had Streptococcus pneumoniae from middle ear culture, there were only 3 bacteriologic failures; there was no relationship between plasma fa AUC(0-24):MIC ratio and outcome. In conclusion, population pharmacokinetic/phamacodynamic methods allowed estimation of drug exposure using one sample per patient. (c) 2007 Elsevier Inc. All rights reserved.
引用
收藏
页码:67 / 74
页数:8
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