Evidence map›Paper›PMID 33903114›Full record

Observational studyAntimicrobial agents and chemotherapy2021

External Evaluation of Two Pediatric Population Pharmacokinetics Models of Oral Trimethoprim and Sulfamethoxazole.

Yi Shuan S Wu, Michael Cohen-Wolkowiez, Christoph P Hornik, Jacqueline G Gerhart, Julie Autmizguine, Marjan Cobbaert, Daniel Gonzalez, Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee

2 registry-linked trialsAbstract readObservational Study
In one paragraph

Observational study in Antimicrobial agents and chemotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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:
NCT02475876 phase1completednot on this map

Pharmacokinetics of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children Using PBPK

TypeinterventionalSponsorMichael Cohen-WolkowiezRan2015 to 2020Enrolled51ConditionsBacterial InfectionsArmsClindamycin, trimethoprim-sulfamethoxazole
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. 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

8 authors.

Yi Shuan S WuDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Michael Cohen-WolkowiezDuke Clinical Research Institute, Durham, North Carolina, USA.
Christoph P HornikDuke Clinical Research Institute, Durham, North Carolina, USA.
Jacqueline G GerhartDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Julie AutmizguineResearch Center, CHU Sainte-Justine, Montréal, Quebec, Canada.
Marjan CobbaertDuke Clinical Research Institute, Durham, North Carolina, USA.
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.
Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee

Funding

Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary DysplasiaR33HL147833 · NHLBI · DUKE UNIVERSITY · PI HORNIK, CHRISTOPH, LAUGHON, MATTHEW · 2021 to 2023
$6.8M
Global Pediatric Clinical Trials NetworkU18FD006298 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL, HORNIK, CHRISTOPH · 2017 to 2021
$5.5M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
Physiologically-Based Pharmacokinetic Modeling to Guide Drug Dosing in Children with ObesityR01HD096435 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DUMOND, JULIE BRUMER · 2018 to 2022
$2.0M
Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary DysplasiaR01FD006099 · FDA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAUGHON, MATTHEW · 2018 to 2022
$2.0M
Enhancement Training for the Next Generation of Translational Ph.D. ScientistsT32GM122741 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WOLBERG, ALISA S., YEH, JEN JEN · 2018 to 2022
$898k
Mentoring in Clinical Pharmacology and Early Phase TrialsK24AI143971 · NIAID · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2019 to 2023
$895k
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
Pharmacokinetics, Pharmacodynamics, and Safety of Methylprednisolone in Neonates on Cardiopulmonary BypassK23HD090239 · NICHD · DUKE UNIVERSITY · PI HORNIK, CHRISTOPH · 2017 to 2020
$646k
Pediatric Critical Care Research Landscape - A National Expert ConferenceR13HD102136 · NICHD · DUKE UNIVERSITY · PI HORNIK, CHRISTOPH, ZIMMERMAN, KANECIA OBIE · 2020 to 2020
$60k
FDA HHS R01 FD006099FDA HHS U18 FD006298NHLBI NIH HHS R33 HL147833NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500006CNIAID NIH HHS K24 AI143971NICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS HHSN275201700002CNICHD NIH HHS K23 HD083465NICHD NIH HHS K23 HD090239NICHD NIH HHS R01 HD076676NICHD NIH HHS R01 HD096435NICHD NIH HHS R13 HD102136NIGMS NIH HHS T32 GM122741
6 · The paper itself

Abstract

The antibiotic combination trimethoprim (TMP)-sulfamethoxazole (SMX) has a broad spectrum of activity and is used for the treatment of numerous infections, but pediatric pharmacokinetic (PK) data are limited. We previously published population PK (popPK) models of oral TMP-SMX in pediatric patients based on sparse opportunistically collected data (POPS study) (J. Autmizguine, C. Melloni, C. P. Hornik, S. Dallefeld, et al., Antimicrob Agents Chemother 62:e01813-17, 2017, https://doi.org/10.1128/AAC.01813-17). We performed a separate PK study of oral TMP-SMX in infants and children with more-traditional PK sample collection and independently developed new popPK models of TMP-SMX using this external data set. The POPS data set and the external data set were each used to evaluate both popPK models. The external TMP model had a model and error structure identical to those of the POPS TMP model, with typical values for PK parameters within 20%. The external SMX model did not identify the covariates in the POPS SMX model as significant. The external popPK models predicted higher exposures to TMP (median overprediction of 0.13 mg/liter for the POPS data set and 0.061 mg/liter for the external data set) and SMX (median overprediction of 1.7 mg/liter and 0.90 mg/liter) than the POPS TMP (median underprediction of 0.016 mg/liter and 0.39 mg/liter) and SMX (median underprediction of 1.2 mg/liter and 14 mg/liter) models. Nonetheless, both models supported TMP-SMX dose increases in infants and young children for resistant pathogens with a MIC of 1 mg/liter, although the required dose increase based on the external model was lower. (The POPS and external studies have been registered at ClinicalTrials.gov under registration no. NCT01431326 and NCT02475876, respectively.).

Indexed as

Anti-Bacterial AgentsChildChild, PreschoolHumansInfantTrimethoprim, Sulfamethoxazole Drug CombinationAnti-Bacterial AgentsTrimethoprim, Sulfamethoxazole Drug Combinationand sulfamethoxazolepediatricpopulation pharmacokineticssulfamethoxazoletrimethoprim

Identifiers

PMID33903114
PMCPMC8407045

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.