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Antimicrob Agents Chemother. 2019 Mar 25. pii: AAC.00284-19. doi: 10.1128/AAC.00284-19. [Epub ahead of print]

Rifampin Pharmacokinetics and Safety in Preterm and Term Infants.

Author information

1
Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA brian.smith@duke.edu.
2
Division of Neonatal-Perinatal Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
3
Division of Neonatology, University of Florida College of Medicine - Jacksonville, UF Health and Wolfson Children's Hospital, Jacksonville, Florida, USA.
4
University of Louisville, Kosair Charities Pediatric Clinical Research Unit and Norton Children's Hospital, Louisville, Kentucky, USA.
5
Department of Pediatrics, Riley Hospital for Children, Indiana University, Indianapolis, Indiana, USA.
6
Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
7
Emmes Corporation, Rockville, Maryland, USA.
8
Department of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Abstract

Rifampin is active against methicillin-resistant staphylococcal species and tuberculosis (TB). We performed a multicenter, prospective pharmacokinetic (PK) and safety study of intravenous rifampin in infants <121 days postnatal age (PNA). We enrolled 27 infants; the median (range) gestational age was 26 weeks (23-41), and PNA was 10 days (0-84). We collected 102 plasma PK samples from 22 of the infants and analyzed safety data from all 27 infants. We analyzed the data using a population PK approach. Rifampin PK was best characterized by a one-compartment model; drug clearance increased with increasing size (body weight) and maturation (PNA). There were no adverse events related to rifampin. Simulated weight and PNA-based intravenous dosing regimens administered once daily (<14 days PNA, 8 mg/kg; ≥14 days PNA, 15 mg/kg) in infants resulted in comparable exposures to adults receiving therapeutic doses of rifampin against Staphylococci infections and TB.

PMID:
30910891
DOI:
10.1128/AAC.00284-19

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