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Purpose

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Conditions

Eligibility

Eligible Ages
Between 0 Years and 20 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Participant is < 21 years of age 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

  1. Participant has a known pregnancy Below exclusion criteria apply only to: 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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: 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 names:
    • Aminocaproic acid
    • Amiodarone
    • Bosentan
    • Budesonide
    • Cefdinir
    • Cefepime
    • Ceftazidime
    • Clindamycin
    • Clobazam
    • Dexamethasone
    • Dexmedetomidine
    • Dextroamphetamine/Amphetamine
    • Fosfomycin
    • Furosemide
    • Gabapentin
    • Guanfacine
    • Hydrocortisone
    • Labetalol
    • Meropenem
    • Metformin
    • Milrinone
    • Nalbuphine
    • Nicardipine
    • Nifedipine
    • Oseltamivir
    • Oxycodone
    • Risperidone
    • Sertraline
    • Sevelamer Carbonate / Sevelamer Hydrochloride
    • Spironolactone
    • Terbutaline
    • Tranexamic acid
    • Voriconazole
    • Zolpidem
    • Azithromycin
    • Lopinavir/Ritonavir
    • Ribavirin
    • Tocilizumab
    • Anakinra
    • Aspirin
    • Canakinumab
    • Colchicine
    • Interferon
    • Remdesivir
    • Ruxolitinib
    • Sarilumab
    • Abatacept
    • Infliximab

Recruiting Locations

Arkansas Children's Hospital Research Institute
Little Rock 4119403, Arkansas 4099753 72202
Contact:
Haley Spradin
501-364-5023
spradlinhe@archildrens.org

University of California, Los Angeles Medical Center
Los Angeles 5368361, California 5332921 90095
Contact:
Michelle Carter
310-206-6369
mfcarter@mednet.ucla.edu

Lucile Packard Children's Hospital
Palo Alto 5380748, California 5332921 94304
Contact:
Yasaman Nourkhala
650-724-4548
yasinour@stanford.edu

Colorado University Denver
Aurora 5412347, Colorado 5417618 80045
Contact:
Lexi Petruccelli
720-777-9881
lexi.petruccelli@childrenscolorado.org

The Children's Hospital Colorado
Aurora 5412347, Colorado 5417618 80045
Contact:
Rebecca Bernstein
720-777-2714
rebecca.bernstein@childrenscolorado.org

University of Florida Jacksonville Shands Medical Center
Jacksonville 4160021, Florida 4155751 32209
Contact:
Amna Riaz
904-244-3059
amna.riaz@jax.ufl.edu

Kapiolani Womens and Childrens Medical Center
Honolulu 5856195, Hawaii 5855797 96826
Contact:
Moara Santos
808-535-7829
moara.palma@hawaiipacifichealth.org

Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago 4887398, Illinois 4896861 60611
Contact:
Ally Byrd
312-227-0067
albyrd@luriechildrens.org

Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago 4887398, Illinois 4896861 60614
Contact:
Harrison Lee
312-227-4668
halee@luriechildrens.org

Riley Hospital for Children at Indiana University
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Jessica Mendoza
317-278-7858
jkmendoz@iu.edu

University of Iowa Stead Family Children's Hospital
Iowa City 4862034, Iowa 4862182 52242
Contact:
Maureen Austin
319-356-0378
maureen-austin@uiowa.edu

University of Louisville Norton Childrens Hospital
Louisville 4299276, Kentucky 6254925 40202
Contact:
Madison Jessie
502-588-3070
madison.ray.1@louisville.edu

Ochsner Baptist Clinical Trials Unit
New Orleans 4335045, Louisiana 4331987 70115
Contact:
Nadrine Hayden
504-897-5811
nadrine.hayden@ochsner.org

Massachusetts General Hospital
Lexington 4941935, Massachusetts 6254926 02421
Contact:
Heli Patel
781-860-1784
hpatel24@mgh.harvard.edu

University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
Contact:
Emily Fratesi
601-815-4179
ekfratesi@umc.edu

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68114
Contact:
Joann Von Bonn
402-836-9756
jvonbon@unmc.edu

University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Sneha Makhijani
984-974-7865
sneha_makhijani@med.unc.edu

Duke University Health System
Durham 4464368, North Carolina 4482348 27710
Contact:
Melissa Harward
919-668-3910
melissa.harward@dm.duke.edu

Cincinnati Childrens Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
Contact:
Aine Powell
513-636-0674
aine.powell@cchmc.org

Cincinnati Childrens Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
Contact:
Luana Johnson
513-803-0854
luana.johnson@cchmc.org

Board of Regents of the University of Oklahoma
Oklahoma City 4544349, Oklahoma 4544379 73104
Contact:
Tracy Jones
405-271-5211
tracy-jones@ouhsc.edu

Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
Contact:
Kyle Patubo
503-494-2797
patubo@ohsu.edu

Pennsylvania State University--Hershey Children's Hospital
Hershey 5193342, Pennsylvania 6254927 17033
Contact:
Courtney Byrnes
717-531-0003
cbyrnes@pennstatehealth.psu.edu

Medical University of South Carolina Children's Hospital
Charleston 4574324, South Carolina 4597040 29425
Contact:
Mary Freeman
843-792-5762
freemanme@musc.edu

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville 4644585, Tennessee 4662168 37232
Contact:
Harrison Moody
615-322-0558
harrison.j.moody@vumc.org

Dell Children's Medical Center of Central Texas
Austin 4671654, Texas 4736286 78723
Contact:
Jennifer Jaimes
512-324-4000
jennifer.jaimes@austin.utexas.edu

University of Texas--Memorial Hermann Texas Medical Center
Houston 4699066, Texas 4736286 77030
Contact:
Elizabeth Aguilera
713-500-5806
elizabeth.aguilera@uth.tmc.edu

The Womens Hospital of Texas
Houston 4699066, Texas 4736286 77054
Contact:
Joanna Williams
281-743-2941
joanna.williams2@hcahealthcare.com

University of Utah
Salt Lake City 5780993, Utah 5549030 84113
Contact:
Fumiko Alger
801-213-7372
fumiko.alger@hsc.utah.edu

Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
Contact:
Megan Kelton
206-987-5539
megan.kelton@seattlechildrens.org

University of Wisconsin
Madison 5261457, Wisconsin 5279468 53705
Contact:
Lensy Porior
608-228-4940
larce@wisc.edu

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Sadaf Shad
414-266-7426
sshad@mcw.edu

More Details

NCT ID
NCT04278404
Status
Recruiting
Sponsor
Duke University

Study Contact

Chi Hornik
(919) 260-7626
chi.hornik@duke.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.