In:
Pediatric Infectious Disease Journal, Ovid Technologies (Wolters Kluwer Health), Vol. 40, No. 4 ( 2021-04), p. 317-323
Abstract:
Infections with Gram-positive bacteria, including acute bacterial skin and skin structure infections (ABSSSIs), are common in children. We describe a single-dose pharmacokinetics and safety study of tedizolid phosphate, a new oxazolidinone under investigation for the treatment of ABSSSIs in children, in hospitalized participants 2 to 〈 12 years of age. Methods: This open-label, multicenter, phase 1 trial (NCT02750761) enrolled hospitalized children 2 to 〈 12 years of age receiving treatment for a confirmed/suspected Gram-positive bacterial infection. Participants were stratified by age (2 to 〈 6 years and 6 to 〈 12 years) to receive a single oral or intravenous dose of tedizolid phosphate. Evaluations included safety and pharmacokinetics of tedizolid phosphate and its active metabolite, tedizolid. Palatability of the oral suspension was also evaluated. Results: Thirty-two participants were enrolled and received 3–6 mg/kg of study medication. For both routes of administration, tedizolid phosphate was rapidly converted to tedizolid; median time to maximum tedizolid plasma concentration was 1–2 hours after initiation of the 1-hour intravenous infusion and 2–3 hours after oral dosing. The tedizolid mean terminal half-life was 5–6 hours and 6–7 hours for the intravenous and oral administration groups, respectively. The oral tedizolid phosphate suspension demonstrated high bioavailability comparable to that of the parenteral administration. A single dose of intravenous or oral tedizolid phosphate was well tolerated; no unexpected safety findings were observed. Conclusions: Pharmacokinetic and safety observations provide the information necessary for the continued development of tedizolid phosphate for the treatment of Gram-positive infections in children, particularly ABSSSIs.
Type of Medium:
Online Resource
ISSN:
0891-3668
DOI:
10.1097/INF.0000000000003030
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2021
detail.hit.zdb_id:
2020216-7
