Evidence map›Paper›PMID 30910891›Full record

Trial reportAntimicrobial agents and chemotherapy2019

Rifampin Pharmacokinetics and Safety in Preterm and Term Infants.

P Brian Smith, C Michael Cotten, Mark L Hudak, Janice E Sullivan, Brenda B Poindexter, Michael Cohen-Wolkowiez, Felix Boakye-Agyeman, Andrew Lewandowski, Ravinder Anand, Daniel K Benjamin and 2 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01728363 (Pharmacokinetics of Antistaphylococcal Antibiotics in Infants), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01728363 phase1completednot on this map

Pharmacokinetics of Antistaphylococcal Antibiotics in Infants

TypeinterventionalSponsorPhillip Brian SmithRan2013 to 2015Enrolled63ConditionsSystemic InfectionArmsAntibiotic
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Rifampicin for COVID-19.World journal of virology · 2022
    Review
  7. Article
  8. Association between neonatal intensive care unit medication safety practices, adverse events, and death.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

P Brian SmithDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA brian.smith@duke.edu.
C Michael CottenDivision of Neonatal-Perinatal Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Mark L HudakDivision of Neonatology, University of Florida College of Medicine-Jacksonville, UF Health and Wolfson Children's Hospital, Jacksonville, Florida, USA.
Janice E SullivanUniversity of Louisville, Kosair Charities Pediatric Clinical Research Unit and Norton Children's Hospital, Louisville, Kentucky, USA.
Brenda B PoindexterDepartment of Pediatrics, Riley Hospital for Children, Indiana University, Indianapolis, Indiana, USA.
Michael Cohen-WolkowiezDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Felix Boakye-AgyemanDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Andrew LewandowskiEmmes Corporation, Rockville, Maryland, USA.
Ravinder AnandEmmes Corporation, Rockville, Maryland, USA.
Daniel K BenjaminDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Matthew M LaughonDepartment of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee

Funding

Project-005U2COD023375 · OD · DUKE UNIVERSITY · PI JUNFENG ZHANG · 2016 to 2026
$215.9M
COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., BERNARD, GORDON RAPHAEL · 2016 to 2022
$177.0M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
NCATS NIH HHS U24 TR001608NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500006CNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD076676NIH HHS U2C OD023375
6 · The paper itself

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 of <121 days postnatal age (PNA). We enrolled 27 infants; the median (range) gestational age was 26 weeks (23 to 41 weeks), and the median PNA was 10 days (0 to 84 days). 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 staphylococcal infections and TB. (This study has been registered at ClinicalTrials.gov under identifier NCT01728363.).

Indexed as

FemaleGestational AgeHumansInfantInfant, NewbornInfant, PrematureMaleProspective StudiesRifampinStaphylococcal InfectionsTuberculosisRifampininfantsMRSApediatricspopulation pharmacokineticsrifampinsafety

Identifiers

PMID30910891
PMCPMC6535522

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.