Pharmacokinetics of Off Label Pediatric Medications

NCT ID: NCT01286519

Last Updated: 2025-05-31

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2035-12-31

Brief Summary

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The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.

Detailed Description

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There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.

Conditions

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Off Label Use of Medications in Pediatric Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children less than 8 years of age
* Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care

Exclusion Criteria

* Lack of consent
Minimum Eligible Age

1 Day

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew M. Laughon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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University of North Carolina NC Children's Hospital

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sneha Makhijani, BS

Role: CONTACT

(984) 974-7865

Facility Contacts

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Sneha Makhijani, MS, RN

Role: primary

984-974-7865

Other Identifiers

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10-0865

Identifier Type: -

Identifier Source: org_study_id

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