title: Pharmacokinetics and pharmacodynamics of gatifloxacin in children with recurrent otitis media: application of sparse sampling in clinical development.
abstract: 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 fu AUC(0-24):MIC ratio and outcome. In conclusion, population pharmacokinetic/pharmacodynamic methods allowed estimation of drug exposure using one sample per patient.
authors: Institute for Clinical Pharmacodynamics, Ordway Research Institute, Albany, NY 12206, USA. crubino-icpd@ordwayresearch.org
authors: Christopher M
authors: CM
authors: Rubino
authors: Paul
authors: P
authors: Ambrose
authors: Brenda
authors: B
authors: Cirincione
authors: Adriano
authors: A
authors: Arguedas
authors: Lawrence
authors: L
authors: Sher
authors: Eduardo
authors: E
authors: Lopez
authors: Xavier
authors: X
authors: Sáez-Llorens
authors: Dennis M
authors: DM
authors: Grasela
mesh_terms: D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000077734:Gatifloxacin; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D013296:Streptococcus pneumoniae / Q000187:drug effects
chemical_list: D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D000077734:Gatifloxacin