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Antimicrobial Agents and Chemotherapy, May 2000, p. 1195-1199, Vol. 44, No. 5
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Pharmacokinetics of a Fluoronaphthyridone, Trovafloxacin (CP 99,219), in Infants and Children following Administration of a Single Intravenous Dose of Alatrofloxacin

John S. Bradley,1,2,* Gregory L. Kearns,3 Michael D. Reed,4 Edmund V. Capparelli,2 John Vincent,5 and The Pediatric Pharmacology Research Unit Networkdagger

Division of Infectious Diseases, Children's Hospital and Health Center,1 and Department of Pediatrics, University of California,2 San Diego, California; Section of Pediatric Clinical Pharmacology and Experimental Therapeutics, Children's Mercy Hospital, and the Departments of Pediatrics and Pharmacology, University of Missouri, Kansas City, Missouri3; Division of Pediatric Pharmacology and Critical Care, Rainbow Babies and Children's Hospital, and Department of Pediatrics, School of Medicine, Case Western Reserve University, Cleveland, Ohio4; and Pfizer Central Research, Groton, Connecticut5

Received 14 June 1999/Returned for modification 18 September 1999/Accepted 8 January 2000

The pharmacokinetics of trovafloxacin following administration of a single intravenous dose of alatrofloxacin, equivalent to 4 mg of trovafloxacin per kg of body weight, were determined in 6 infants (ages 3 to 12 months) and 14 children (ages, 2 to 12 years). There was rapid conversion of alatrofloxacin to trovafloxacin, with an average ± standard deviation (SD) peak trovafloxacin concentration determined at the end of the infusion of 4.3 ± 1.4 µg/ml. The primary pharmacokinetic parameters (average ± SD) analyzed were volume of distribution at steady state (1.6 ± 0.6 liters/kg), clearance (151 ± 82 ml/h/kg), and half-life (9.8 ± 2.9 h). The drug was well tolerated by all children. There were no age-related differences in any of the pharmacokinetic parameters studied. Less than 5% of the administered dose was excreted in the urine over 24 h. On the basis of the mean area under the concentration-time curve of 30.5 ± 10.1 µg · h/ml and the susceptibility (<= 0.5 µg/ml) of common pediatric bacterial pathogens to trovafloxacin, dosing of 4 mg/kg/day once or twice daily should be appropriate.

* Corresponding author. Mailing address: Division of Infectious Diseases, Children's Hospital San Diego, 3020 Children's Way MC 5041, San Diego, CA 92123. Phone: (858) 495-7785. Fax: (858) 571-3372. E-mail: jbradley{at}chsd.org.

dagger Children's Hospital/University of California, San Diego; Arkansas Children's Hospital, Little Rock; Rainbow Babies and Children's Hospital, Cleveland, Ohio; Children's Mercy Hospital, Kansas City, Mo.; Children's Hospital of Columbus, Columbus, Ohio; Louisiana State University Medical Center, Shreveport; and LeBonheur Children's Hospital, Memphis, Tenn.

Antimicrobial Agents and Chemotherapy, May 2000, p. 1195-1199, Vol. 44, No. 5
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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