Evidence map›Paper›PMID 25318626›Full record

Trial reportJournal of neonatal-perinatal medicine2014

Intestinal fatty-acid binding protein and metronidazole response in premature infants.

M R Sampson, B T Bloom, A Arrieta, E Capparelli, D K Benjamin, P B Smith, G L Kearns, J van den Anker, M Cohen-Wolkowiez

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neonatal-perinatal medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

9 authors.

M R SampsonDuke Clinical Research Institute, Durham, NC, USA UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA.
B T BloomWichita Medical Research and Education Foundation, Wichita, KS, USA.
A ArrietaChildren's Hospital-Orange County, Orange, CA, USA.
E CapparelliSchools of Medicine and Pharmacy, University of California-San Diego, La Jolla, CA, USA.
D K BenjaminDuke Clinical Research Institute, Durham, NC, USA Department of Pediatrics, Duke University, Durham, NC, USA.
P B SmithDuke Clinical Research Institute, Durham, NC, USA Department of Pediatrics, Duke University, Durham, NC, USA.
G L KearnsDivision of Pediatric Pharmacology and Therapeutic Innovation, Children's Mercy Hospital, Kansas City, MO, USA Department of Pediatrics, University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.
J van den AnkerDivision of Pediatric Clinical Pharmacology, Children's National Medical Center, Washington, DC, USA.
M Cohen-WolkowiezDuke Clinical Research Institute, Durham, NC, USA Department of Pediatrics, Duke University, Durham, NC, USA.

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
TRAINING & OUTREACH COREU54HD071600 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BRADLEY, JOHN S · 2011 to 2015
$3.6M
Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01HD057956 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2012
$2.8M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
Clinical Practice Data to Aid Narrow Therapeutic Index Drug ClassificationU01FD004858 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2013 to 2014
$497k
FDA HHS U01 FD004858NCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1TR001117NICHD NIH HHS 1K24HD058735-05NICHD NIH HHS 1R01HD057956-05NICHD NIH HHS HHSN275201000003INICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD057956NICHD NIH HHS U54 HD071600NIDDK NIH HHS HHSN267200700051CNIGMS NIH HHS T32 GM086330
6 · The paper itself

Abstract

objectivesIn premature infants with suspected intra-abdominal infection, biomarkers for treatment response to antimicrobial therapy are lacking. Intestinal fatty acid-binding protein (I-FABP) is specific to the enterocyte and is released in response to intestinal mucosal injury. I-FABP has not been evaluated as a surrogate marker of disease response to antimicrobial therapy. We examined the relationship between metronidazole exposure and urinary I-FABP concentrations in premature infants with suspected intra-abdominal infection. STUDY

designWe conducted an intravenous metronidazole pharmacokinetic study, collecting ≤3 urine samples per infant for I-FABP concentration measurements. We analyzed the relationship between I-FABP concentrations and measures of metronidazole exposure and pharmacokinetics, maturational factors, and other covariates.

resultsTwenty-six samples from 19 premature infants were obtained during metronidazole treatment. When analyzed without regard to presence of necrotic gastrointestinal disease, there were no significant associations between predictor variables and I-FABP concentrations. However, when the sample was limited to premature infants with necrotic gastrointestinal disease, an association was found between average predicted metronidazole concentration and I-FABP concentration (p = 0.006).

conclusionWhile a predictive association between urinary I-FABP and metronidazole systemic exposure was not observed, the data suggest the potential of this endogenous biomarker to serve as a pharmacodynamic surrogate for antimicrobial treatment of serious abdominal infections in neonates and infants.

Indexed as

Anti-Infective AgentsBiomarkersEnterocolitis, NecrotizingFatty Acid-Binding ProteinsFemaleHumansInfant, NewbornInfant, PrematureInfant, Premature, DiseasesInfusions, IntravenousIntraabdominal InfectionsLinear ModelsMaleMetronidazoleProspective StudiesTreatment OutcomeAnti-Infective AgentsBiomarkersFatty Acid-Binding ProteinsMetronidazoleantimicrobial agentsbiomarkersNecrotizing enterocolitispharmacokineticspremature infants

Identifiers

PMID25318626
PMCPMC4225165

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Registered trials

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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.