Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
NCT ID: NCT04278404
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2020-03-05
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Children and young adults who are prescribed drugs of interest
Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.
The 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:
The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.
Interventions
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The 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:
The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria
Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)
2. Has had intermittent dialysis within previous 24 hours
3. Has had a kidney transplant within previous 30 days
4. Has had a liver transplant within previous 1 year
5. Has had a stem cell transplant within previous 1 year
6. Has had therapeutic hypothermia within previous 24 hours
7. Has had plasmapheresis within the previous 24 hours
8. Has a Ventricular Assist Device
9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
0 Years
20 Years
ALL
Yes
Sponsors
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The Emmes Company, LLC
INDUSTRY
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Chi Hornik
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
University of California, Los Angeles Medical Center
Los Angeles, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
Colorado University Denver
Aurora, Colorado, United States
The Children's Hospital Colorado
Aurora, Colorado, United States
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
University of Florida Jacksonville Shands Medical Center
Jacksonville, Florida, United States
Kapiolani Womens and Childrens Medical Center
Honolulu, Hawaii, United States
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children at Indiana University
Indianapolis, Indiana, United States
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, United States
University of Kansas Medical Center-JG Kidney Institute
Kansas City, Kansas, United States
University of Louisville Norton Childrens Hospital
Louisville, Kentucky, United States
Tulane University Health Science Center
New Orleans, Louisiana, United States
Ochsner Baptist Clinical Trials Unit
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Lexington, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Mississippi Center for Advanced Medicine
Madison, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Pennsylvania State University--Hershey Children's Hospital
Hershey, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States
University of South Carolina
Columbia, South Carolina, United States
Avera McKennan Hospital & University Medical Center
Sioux Falls, South Dakota, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
University of Texas-Southwestern Medical Center Dallas
Dallas, Texas, United States
University of Texas--Memorial Hermann Texas Medical Center
Houston, Texas, United States
The Womens Hospital of Texas
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
University Wisconsin Madison
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Autmizguine J, Melloni C, Hornik CP, Dallefeld S, Harper B, Yogev R, Sullivan JE, Atz AM, Al-Uzri A, Mendley S, Poindexter B, Mitchell J, Lewandowski A, Delmore P, Cohen-Wolkowiez M, Gonzalez D; the Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Trimethoprim-Sulfamethoxazole in Infants and Children. Antimicrob Agents Chemother. 2017 Dec 21;62(1):e01813-17. doi: 10.1128/AAC.01813-17. Print 2018 Jan.
Dallefeld SH, Atz AM, Yogev R, Sullivan JE, Al-Uzri A, Mendley SR, Laughon M, Hornik CP, Melloni C, Harper B, Lewandowski A, Mitchell J, Wu H, Green TP, Cohen-Wolkowiez M. A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):419-430. doi: 10.1007/s10928-018-9576-y. Epub 2018 Feb 12.
Hornik CP, Gonzalez D, van den Anker J, Atz AM, Yogev R, Poindexter BB, Ng KC, Delmore P, Harper BL, Melloni C, Lewandowski A, Gelber C, Cohen-Wolkowiez M, Lee JH; Pediatric Trial Network Steering Committee. Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children. J Clin Pharmacol. 2018 Aug;58(8):1092-1104. doi: 10.1002/jcph.1116. Epub 2018 Apr 20.
Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C; Pediatric Trials Network Steering Committee (See Acknowledgments for a listing of committee members.). Systemic timolol exposure following topical application to infantile hemangiomas. J Am Acad Dermatol. 2020 Mar;82(3):733-736. doi: 10.1016/j.jaad.2019.02.029. Epub 2019 Feb 18. No abstract available.
Tremoulet A, Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Salgado A, Ian-U Chong S, Melloni C, Gao J, Benjamin DK Jr, Capparelli EV, Cohen-Wolkowiez M; Administrative Core Committee of the Best Pharmaceuticals for Children Act-Pediatric Trials Network. Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design. Antimicrob Agents Chemother. 2014 Jun;58(6):3013-20. doi: 10.1128/AAC.02374-13. Epub 2014 Mar 10.
Hornik CP, Benjamin DK Jr, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, Ericson JE, Clark RH, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network. Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates. J Pediatr. 2016 Nov;178:125-129.e1. doi: 10.1016/j.jpeds.2016.07.011. Epub 2016 Aug 10.
Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Blackford M, Yogev R, James LP, Melloni C, Harper B, Mitchell J, Benjamin DK Jr, Boakye-Agyeman F, Cohen-Wolkowiez M. Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates. Ther Drug Monit. 2018 Feb;40(1):103-108. doi: 10.1097/FTD.0000000000000466.
Gonzalez D, Melloni C, Yogev R, Poindexter BB, Mendley SR, Delmore P, Sullivan JE, Autmizguine J, Lewandowski A, Harper B, Watt KM, Lewis KC, Capparelli EV, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Administrative Core Committee. Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents. Clin Pharmacol Ther. 2014 Oct;96(4):429-37. doi: 10.1038/clpt.2014.134. Epub 2014 Jun 20.
Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK Jr, Laughon MM. Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2888-94. doi: 10.1128/AAC.03086-15. Print 2016 May.
Gonzalez D, Melloni C, Poindexter BB, Yogev R, Atz AM, Sullivan JE, Mendley SR, Delmore P, Delinsky A, Zimmerman K, Lewandowski A, Harper B, Lewis KC, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act--Pediatric Trials Network Administrative Core Committee. Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots. Bioanalysis. 2015;7(9):1137-49. doi: 10.4155/bio.15.38.
Hornik CP, Yogev R, Mourani PM, Watt KM, Sullivan JE, Atz AM, Speicher D, Al-Uzri A, Adu-Darko M, Payne EH, Gelber CE, Lin S, Harper B, Melloni C, Cohen-Wolkowiez M, Gonzalez D; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Milrinone in Infants, Children, and Adolescents. J Clin Pharmacol. 2019 Dec;59(12):1606-1619. doi: 10.1002/jcph.1499. Epub 2019 Jul 17.
Related Links
Access external resources that provide additional context or updates about the study.
Food and Drug Administration. General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products
Extracorporeal Life Support Organization (ELSO). ECLS Registry Report: International Summary Ann Arbor, MI: Extracorporeal Life Support Organization (ELSO); 2020
Wildschut E, editor. Drug therapies in neonates and children during extracorporeal membrane oxygenation (ECMO); Keep your eyes open. Rotterdam, The Netherlands: Erasmus MC; 2010.
Other Identifiers
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Pro00103838
Identifier Type: -
Identifier Source: org_study_id
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