Evidence map›Paper›PMID 26926644›Full record

ArticleAntimicrobial agents and chemotherapy2016

Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants.

Daniel Gonzalez, Paula Delmore, Barry T Bloom, C Michael Cotten, Brenda B Poindexter, Elisabeth McGowan, Karen Shattuck, Kathleen K Bradford, P Brian Smith, Michael Cohen-Wolkowiez and 4 more

3 registry-linked trialsOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2016. 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 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
3.7field-weighted citation impact, top 8% 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:
NCT01728363 phase1completednot on this map

Pharmacokinetics of Antistaphylococcal Antibiotics in Infants

TypeinterventionalSponsorPhillip Brian SmithRan2013 to 2015Enrolled63ConditionsSystemic InfectionArmsAntibiotic
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

17 citing papers in PubMed, 36 citations in OpenAlex.

  1. Trial
  2. Pharmacokinetics of Clindamycin in Obese and Nonobese Children.Antimicrobial agents and chemotherapy · 2017
    Trial
  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
    Article
  5. CDC Guidelines for the Prevention and Treatment of Anthrax, 2023.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2023
    Article
  6. Review
  7. Review
  8. Article
  9. 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
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. 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

14 authors at 8 institutions in 1 country.

Daniel GonzalezDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Paula DelmoreDepartment of Neonatology, Wesley Medical Center, Wichita, Kansas, USA.
Barry T BloomDepartment of Neonatology, Wesley Medical Center, Wichita, Kansas, USA.
C Michael CottenDepartment of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
Brenda B PoindexterDepartment of Pediatrics, Riley Hospital for Children, Indiana University, Indianapolis, Indiana, USA.
Elisabeth McGowanFloating Hospital for Children at Tufts Medical Center, Boston, Massachusetts, USA.
Karen ShattuckDepartment of Pediatrics, University of Texas Medical Branch, Galveston, Texas, USA.
Kathleen K BradfordDepartment of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
P Brian SmithDepartment of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Michael Cohen-WolkowiezDepartment of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Maurine MorrisDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Wanrong YinEmmes Corporation, Rockville, Maryland, USA.
Daniel K BenjaminDepartment of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA Duke 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 matt_laughon@med.unc.edu.
Duke University · USUniversity of North Carolina at Chapel Hill · USWesley Medical Center · USClinical Research Institute · USEmmes (United States) · USRiley Hospital for Children · USThe University of Texas Medical Branch at Galveston · USTufts Children's Hospital · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Increasing the Quality and Efficiency of Clinical Trials (R18)R18FD005292 · FDA · DUKE UNIVERSITY · PI LI, JENNIFER S · 2014 to 2019
$26.8M
Fungal biomarkers for diagnosis and response to therapy for pediatric candidemiaR01HD081044 · NICHD · DUKE UNIVERSITY · PI FISHER, BRIAN T, STEINBACH, WILLIAM J · 2014 to 2018
$3.2M
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
Use of Physiologically-Based PK/PD Models to Streamline Drug ApprovalsK23HD083465 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GONZALEZ, DANIEL · 2015 to 2019
$727k
Antimicrobial pharmacokinetics and outcomes in vulnerable infantsK23HD068497 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2011 to 2015
$586k
Clinical Practice Data to Aid Narrow Therapeutic Index Drug ClassificationU01FD004858 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2013 to 2014
$497k
FDA HHS R18 FD005292FDA HHS U01 FD004858NCATS NIH HHS UL1 TR001117NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500006CNICHD NIH HHS HHSN267200700051CNICHD NIH HHS HHSN275201000001GNICHD NIH HHS HHSN275201000001ZNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K23 HD068497NICHD NIH HHS K23 HD083465NICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD076676NICHD NIH HHS R01 HD081044
6 · The paper itself

Abstract

Clindamycin may be active against methicillin-resistant Staphylococcus aureus, a common pathogen causing sepsis in infants, but optimal dosing in this population is unknown. We performed a multicenter, prospective pharmacokinetic (PK) and safety study of clindamycin in infants. We analyzed the data using a population PK analysis approach and included samples from two additional pediatric trials. Intravenous data were collected from 62 infants (135 plasma PK samples) with postnatal ages of <121 days (median [range] gestational age of 28 weeks [23 to 42] and postnatal age of 17 days [1 to 115]). In addition to body weight, postmenstrual age (PMA) and plasma protein concentrations (albumin and alpha-1 acid glycoprotein) were found to be significantly associated with clearance and volume of distribution, respectively. Clearance reached 50% of the adult value at PMA of 39.5 weeks. Simulated PMA-based intravenous dosing regimens administered every 8 h (≤32 weeks PMA, 5 mg/kg; 32 to 40 weeks PMA, 7 mg/kg; >40 to 60 weeks PMA, 9 mg/kg) resulted in an unbound, steady-state concentration at half the dosing interval greater than a MIC for S. aureus of 0.12 μg/ml in >90% of infants. There were no adverse events related to clindamycin use. (This study has been registered at ClinicalTrials.gov under registration no. NCT01728363.).

Indexed as

Anti-Bacterial AgentsClindamycinFemaleHumansInfantInfant, NewbornInfant, PrematureMicrobial Sensitivity TestsModels, TheoreticalPostmenopausePregnancyProspective StudiesStaphylococcus aureusAnti-Bacterial AgentsClindamycin

Identifiers

PMID26926644
PMCPMC4862454
OpenAlexW2291478676

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.