Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design.
Adriana Tremoulet, Jennifer Le, Brenda Poindexter...
https://pubmed.ncbi.nlm.nih.gov/24614374Actively Recruiting
Age: 0Years - 20Years
All Genders
Healthy Volunteers
ID04278404
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care
Led by Duke University · Updated on 2026-04-06
5000
Participants Needed
51
Research Sites
17 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
T
The Emmes Company, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how certain drugs prescribed to children and young adults act within their bodies. The goal is to find the safest and most effective doses for these understudied drugs given as part of standard medical care. This observational study focuses on pharmacokinetics (PK), including how drugs are absorbed, distributed, metabolized, and eliminated, with special attention to participants with conditions such as COVID-19 and Down Syndrome. Participants include children and young adults under 21 years who are either prescribed drugs of interest by their healthcare providers or have tested positive for SARS-CoV-2 within 60 days before enrollment. The study collects bodily fluid samples, like whole blood and effluent samples, to analyze drug behavior. Data collection lasts up to 90 days from consent, extended to 210 days for participants with Down Syndrome at designated sites. During the study, participants undergo PK sampling to measure various drug-related factors such as clearance, volume of distribution, elimination rate, half-life, absorption rate, maximum concentration, and time to reach maximum concentration. Researchers gather data at intervals up to 90 or 210 days, depending on participant status. The study monitors safety and drug effects without altering prescribed treatments, aiming to better understand drug profiles in pediatric and young adult populations.
CONDITIONS
Brief Title
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Who Can Participate
Age: 0Years - 20Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Participant is under 21 years of age
- Parent, legal guardian, or adult participant understands the consent process and agrees to provide informed consent
- Participant is currently receiving one or more of the study drugs of interest or has tested positive for SARS-CoV-2 within 60 days prior to enrollment
You will not qualify if you...
- Participant is known to be pregnant
- Participant has had intermittent dialysis within the previous 24 hours
- Participant has had a kidney transplant within the previous 30 days
- Participant has had a liver transplant within the previous 1 year
- Participant has had a stem cell transplant within the previous 1 year
- Participant has had therapeutic hypothermia within the previous 24 hours
- Participant has had plasmapheresis within the previous 24 hours
- Participant has a Ventricular Assist Device
- Participant has any condition judged by the investigator as unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 90 days or up to 210 days for participants with Down Syndrome at designated sites
Participants who receive drugs of interest as part of their routine medical care are observed through collection of bodily fluid samples to study drug pharmacokinetics and safety.
Visits occur as needed for sample collection during routine care
Trial Site Locations
Total: 51 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Completed
2
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
4
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
5
Colorado University Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
6
The Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Completed
7
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
Completed
8
University of Florida Jacksonville Shands Medical Center
Jacksonville, Florida, United States, 32209
Actively Recruiting
9
Kapiolani Womens and Childrens Medical Center
Honolulu, Hawaii, United States, 96826
Actively Recruiting
10
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60611
Completed
11
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60614
Actively Recruiting
12
Riley Hospital for Children at Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
13
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, United States, 52242
Completed
14
University of Kansas Medical Center-JG Kidney Institute
Kansas City, Kansas, United States, 66160
Completed
15
University of Louisville Norton Childrens Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
16
Tulane University Health Science Center
New Orleans, Louisiana, United States, 70112
Completed
17
Ochsner Baptist Clinical Trials Unit
New Orleans, Louisiana, United States, 70115
Actively Recruiting
18
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Completed
19
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Completed
20
Massachusetts General Hospital
Lexington, Massachusetts, United States, 02421
Completed
21
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Completed
22
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
23
Mississippi Center for Advanced Medicine
Madison, Mississippi, United States, 39110
Completed
24
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Completed
25
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
26
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Completed
27
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87131
Completed
28
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Completed
29
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
30
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Completed
31
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
32
Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
33
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
34
Pennsylvania State University--Hershey Children's Hospital
Hershey, Pennsylvania, United States, 17033
Completed
35
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Completed
36
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States, 29425
Actively Recruiting
37
University of South Carolina
Columbia, South Carolina, United States, 29208
Completed
38
Avera McKennan Hospital & University Medical Center
Sioux Falls, South Dakota, United States, 57108
Completed
39
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
40
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
41
University of Texas-Southwestern Medical Center Dallas
Dallas, Texas, United States, 75390
Active, Not Recruiting
42
University of Texas--Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
Completed
43
The Womens Hospital of Texas
Houston, Texas, United States, 77054
Actively Recruiting
44
University of Utah
Salt Lake City, Utah, United States, 84113
Actively Recruiting
45
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
46
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Active, Not Recruiting
47
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
48
University Wisconsin Madison
Madison, Wisconsin, United States, 53705
Completed
49
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
50
The Hospital for Sick Children
Toronto, Ontario, Canada
Actively Recruiting
51
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
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Research Team
C
Chi Hornik
M
Melissa James, MPH, RD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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