title: Pharmacokinetics, Safety and Tolerability of Single Dose Dalbavancin in Children 12-17 Years of Age.
abstract: BACKGROUND
  Dalbavancin is a lipoglycopeptide antibiotic with Gram-positive activity and novel pharmacokinetic (PK) properties that result in a prolonged terminal half-life of 15.5 days in adults. Once weekly dosing in adults in phase 3 studies of complicated skin and skin structure infections documented dalbavancin exposures associated with clinical and microbiologic efficacy. PK properties have not been examined in children. The primary objective of this open-label, multicenter single-dose phase 1 study was to characterize the PK of dalbavancin in hospitalized pediatric subjects 12-17 years of age.
  
  
  METHODS
  A single dose of 1000 mg of dalbavancin (the standard adult dose) was administered as a 30-minute intravenous infusion to subjects weighing 60 kg or greater and 15 mg/kg for subjects weighing <60 kg. A noncompartmental PK analysis was performed.
  
  
  RESULTS
  The apparent terminal t1/2 was approximately 9 days and was similar for dalbavancin dosages of 1000 mg and 15 mg/kg. Median dalbavancin plasma exposures (Cmax and AUCinf) when administered as 1000 mg to subjects weighing 60 kg or greater were similar to those when dalbavancin was administered at 15 mg/kg to subjects weighing <60 kg and slightly lower than exposures in adults given 1000 mg in prior PK and treatment studies. Single dose dalbavancin was well tolerated.
  
  
  CONCLUSIONS
  Given dalbavancin exposures documented in children 12-17 years of age, and recognized dose proportionality, appropriate dosing can be modeled for pediatric phase 3 trials in acute bacterial skin and skin structure infections, to achieve the same exposure that is reported to be safe and effective in adults.
authors.affiliation: From the *Rady Children's Hospital San Diego, The University of California San Diego School of Medicine, San Diego, California; †Durata Therapeutics, Branford, Connecticut; ‡Institute for Clinical Pharmacodynamics, School of Pharmacy and Pharmaceutical Sciences, The University at Buffalo, Buffalo, New York; § Department of Pediatrics, College of Medicine and Life Sciences, University of Toledo, Toledo, Ohio; and ¶Kosair Children's Hospital, The University of Louisville School of Medicine, Louisville, Kentucky.
authors.forename: John S
authors.initials: JS
authors.lastname: Bradley
authors.forename: Sailaja
authors.initials: S
authors.lastname: Puttagunta
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Rubino
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Blumer
authors.forename: Michael
authors.initials: M
authors.lastname: Dunne
authors.forename: Janice E
authors.initials: JE
authors.lastname: Sullivan
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D002648:Child; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007297:Inpatients; D008297:Male; D017334:Teicoplanin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics
chemical_list: D000900:Anti-Bacterial Agents; D017334:Teicoplanin; C469289:dalbavancin