Pediatric ALLNCT03481881
Pharmacokinetics of Drugs Administered to Children
An observational study of Pediatric ALL, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 20 years
- Conditions the study is for
- Pediatric ALL
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2013to 14 Aug 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver
Who may be able to join
- Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
Who cannot join
- Failure to obtain consent/assent (as indicated)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
Rachel Greenberg, MD, 919-668-4725, rachel.greenberg@duke.edu
About this study
Official title: Pharmacokinetics of Drugs Administered to Children Per Standard of Care
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.
- Conditions
- Pediatric ALL
- Being tested
- Standard of care drug
- Keywords
- pharmacokinetics
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care drugDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
Measured: Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary outcomes (5)
Maximum concentration (Cmax)
Measured: Data will be collected throughout the hospital or outpatient stay up to 90 days
Time to achieve maximum concentration (Tmax)
Measured: Data will be collected throughout the hospital or outpatient stay up to 90 days
Absorption rate constant (ka)
Measured: Data will be collected throughout the hospital or outpatient stay up to 90 days
Elimination rate constant (kel)
Measured: Data will be collected throughout the hospital or outpatient stay up to 90 days
Half-life (t1/2)
Measured: Data will be collected throughout the hospital or outpatient stay up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start14 Aug 2013
- Primary completion14 Aug 2033 (estimated)
- Study completion14 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481881
- Sponsor's protocol ID
- Pro00042519
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2018
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Drugs Administered to Children Per Standard of Care
- ClinicalTrials.gov ID
- NCT03481881
- Acronym / sponsor ID
- Pro00042519
- Conditions
- Pediatric ALL
- Keywords
- pharmacokinetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Aug 2013 (actual)
- Primary completion
- 14 Aug 2033 (estimated)
- Study completion
- 14 Aug 2033 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver
Key inclusion criteria (1 listed)
- Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
Key exclusion criteria (1 listed)
- Failure to obtain consent/assent (as indicated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care drugThis 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. | Drug | – |
Primary outcome
Area under the curve (AUC)
Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
5 secondary outcomes
Maximum concentration (Cmax)
Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Time to achieve maximum concentration (Tmax)
Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Absorption rate constant (ka)
Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Elimination rate constant (kel)
Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Half-life (t1/2)
Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel G Greenberg, MD (9196684725, rachel.greenberg@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) (time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.