Evidence map›Paper›PMID 24949994›Full record

Trial reportClinical pharmacology and therapeutics2014

Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents.

D Gonzalez, C Melloni, R Yogev, B B Poindexter, S R Mendley, P Delmore, J E Sullivan, J Autmizguine, A Lewandowski, B Harper and 6 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
10.6field-weighted citation impact, top 2% of its field
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.

NCT01431326 completednot on this map

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

TypeobservationalSponsorDaniel BenjaminRan2011 to 2019Enrolled3,520ConditionsAdenovirus, Anesthesia, Anxiety, AnxiolysisArmsThe POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
NCT01744730 phase1completednot on this map

Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (NICHD): CLIN01

TypeinterventionalSponsorPhillip Brian SmithRan2013 to 2014Enrolled22ConditionsBacterial Infections, ObesityArmsClindamycin
NCT04278404 recruitingnot on this mapstarted 2020, after this paper: background citation

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

TypeobservationalSponsorDuke UniversityRan2020 to 2026Enrolled5,000ConditionsCoronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, HypertensionArmsThe POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 69 citations in OpenAlex.

  1. Pharmacokinetics of Clindamycin in Obese and Nonobese Children.Antimicrobial agents and chemotherapy · 2017
    Trial
  2. Article
  3. Review
  4. Creativity in Pediatric Clinical Pharmacology: Study Design and Oral Dosage Forms.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
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  6. Review
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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

16 authors at 9 institutions in 1 country.

D Gonzalez1] Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA [2] Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
C MelloniDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
R YogevAnn and Robert H. Lurie Children's Hospital of Chicago, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
B B PoindexterDepartment of Pediatrics, Riley Hospital for Children, Indiana University, Indianapolis, Indiana, USA.
S R MendleyDepartment of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA.
P DelmoreDepartment of Pediatrics, Wesley Medical Center, Wichita, Kansas, USA.
J E SullivanKosair Charities Pediatric Clinical Research Unit, Department of Pediatrics, University of Louisville, Louisville, Kentucky, USA.
J AutmizguineDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
A LewandowskiEMMES Corporation, Rockville, Maryland, USA.
B HarperDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
K M Watt1] Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA [2] Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.
K C LewisOpAns, Durham, North Carolina, USA.
E V CapparelliDepartment of Pediatrics, University of California, San Diego, California, USA.
D K Benjamin1] Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA [2] Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.
M Cohen-Wolkowiez1] Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA [2] Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.
Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee
Clinical Research Institute · USEmmes (United States) · USNorthwestern University · USRiley Hospital for Children · USUniversity of California San Diego · USUniversity of Louisville · USUniversity of Maryland, Baltimore · USUniversity of North Carolina at Chapel Hill · USWesley Medical Center · US

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 CAPPARELLI, EDMUND VINCENT · 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
Physiologically Based Pharmacokinetics in Critically Ill ChildrenK23HD075891 · NICHD · DUKE UNIVERSITY · PI WATT, KEVIN M · 2014 to 2018
$638k
Clinical Practice Data to Aid Narrow Therapeutic Index Drug ClassificationU01FD004858 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2013 to 2014
$497k
Pharmacokinetics and Pharmacodynamics of Antibiotics in Premature InfantsK23HD064814 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2010 to 2013
$474k
FDA HHS 1U01FD004858-01FDA HHS U01 FD004858NCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1TR001117NICHD NIH HHS 1K23HD064814NICHD NIH HHS 1K24HD058735-05NICHD NIH HHS 1R01HD057956-05NICHD NIH HHS HHSN275201000003INICHD NIH HHS K23 HD064814NICHD NIH HHS K23 HD075891NICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD057956NICHD NIH HHS U54 HD071600NIGMS NIH HHS 1T32GM086330-01A1NIGMS NIH HHS T32 GM086330NIGMS NIH HHS T32GM086330
6 · The paper itself

Abstract

Clindamycin is commonly prescribed to treat children with skin and skin-structure infections (including those caused by community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA)), yet little is known about its pharmacokinetics (PK) across pediatric age groups. A population PK analysis was performed in NONMEM using samples collected in an opportunistic study from children receiving i.v. clindamycin per standard of care. The final model was used to optimize pediatric dosing to match adult exposure proven effective against CA-MRSA. A total of 194 plasma PK samples collected from 125 children were included in the analysis. A one-compartment model described the data well. The final model included body weight and a sigmoidal maturation relationship between postmenstrual age (PMA) and clearance (CL): CL (l/h) = 13.7 × (weight/70)(0.75) × (PMA(3.1)/(43.6(3.1) + PMA(3.1))); V (l) = 61.8 × (weight/70). Maturation reached 50% of adult CL values at ~44 weeks PMA. Our findings support age-based dosing.

Indexed as

AdolescentAnti-Bacterial AgentsChildChild, PreschoolClindamycinDose-Response Relationship, DrugFemaleHumansInfantInfant, NewbornInfant, PrematureMaleModels, BiologicalAnti-Bacterial AgentsClindamycin

Identifiers

PMID24949994
PMCPMC4169790
OpenAlexW2016611207

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.