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Pharmacokinetics of Drugs Administered to Children

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ClinicalTrials.gov Identifier: NCT03481881
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This is a prospective study of children <21 years of age with the goal of characterizing the PK of drugs administered per standard of care as prescribed by the treating caregiver.

Condition or disease Intervention/treatment
Pediatric ALL Drug: Standard of care drug

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Drugs Administered to Children Per Standard of Care
Actual Study Start Date : August 14, 2013
Estimated Primary Completion Date : August 14, 2023
Estimated Study Completion Date : August 14, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Standard of care drug
    This study is collecting PK data on children prescribed the following drugs of interest per standard of care: dexmedetomidine, bosentan, furosemide, chlorothiazide, ethacrynic acid, bumetanide, hydromorphone, tacrolimus, ampicillin, gentamicin, caffeine, fentanyl, midazolam, foscarnet, hydroxychloroquine, and moxifloxacin.


Primary Outcome Measures :
  1. Area under the curve (AUC) [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]
  2. Time to achieve maximum concentration (Tmax) [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]
  3. Absorption rate constant (ka) [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]
  4. Elimination rate constant (kel) [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]
  5. Half-life (t1/2) [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children (<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver
Criteria

Inclusion Criteria:

  • Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver

Exclusion Criteria:

  • Failure to obtain consent/assent (as indicated)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481881


Contacts
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Contact: Rachel G Greenberg, MD 9196684725 rachel.greenberg@duke.edu

Locations
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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Rachel Greenberg, MD    919-668-4725    rachel.greenberg@duke.edu   
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03481881     History of Changes
Other Study ID Numbers: Pro00042519
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Duke University:
pharmacokinetics