Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT01431326
• Date of registration: 17/08/2011
• Prospective Registration: Yes
• Primary sponsor: Daniel Benjamin
• Public title: Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care PTN_POPS
• Scientific title: Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
• Date of first enrolment: November 2011
• Target sample size: 3520
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01431326
• Study type: Observational

Countries of recruitment

Australia, Canada, Israel, Singapore, United Kingdom, United States

Contacts

• Name: Chi Hornik, PharmD
• Affiliation: Duke University

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 1) Failure to obtain consent/assent (as indicated)

- 2) Known pregnancy as determined via interview or testing if available.



Age minimum: N/A
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Autism

Autistic Disorder

Bacterial Meningitis

Bipolar Disorder

Chronic Kidney Diseases

Cytomegalovirus Retinitis

Endocarditis

Early-onset Schizophrenia Spectrum Disorders

Epilepsy

Migraines

Schizophrenia

Anxiolysis

Central Nervous System Infections

General Anesthesia

Heart Failure

Heavy Menstrual Bleeding

Intra-abdominal Infections

Pneumonia

Hypokalemia

Pain

Pulmonary Arterial Hypertension

Bacterial Septicemia

Bone and Joint Infections

Cardiac Arrest

Fibrinolytic Bleeding

Adenovirus

Anxiety

Benzodiazepine

Gram-negative Infection

Insomnia

Urinary Tract Infections

Infection

Lower Respiratory Tract Infections

Hemophilia

Herpes Simplex Virus

Infantile Hemangioma

Staphylococcal Infections

Methicillin Resistant Staphylococcus Aureus

Nosocomial Pneumonia

Seizures

Withdrawal

Anesthesia

Cardiac Arrhythmia

CMV Retinitis

Bradycardia

Convulsions

Hypertension

Inflammation

Neuromuscular Blockade

Inflammatory Conditions

Sedation

Skeletal Muscle Spasms

Treatment-resistant Schizophrenia

Gynecologic Infections

Headache

Hyperaldosteronism

Sepsis

Neutropenia

Skin and Skin-structure Infections

Intervention(s)

Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:

Primary Outcome(s)

Composite of pharmacokinetic outcomes for understudied drugs in children [Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days]

Secondary Outcome(s)

Biomarkers associated with understudied drugs in children [Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days]

Composite pharmacodynamic outcomes of understudied drugs in children [Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days]

Secondary ID(s)

HHSN27500043

HHSN27500027

HHSN27500049

IND 114531

HHSN27500020

IND 113645

HHSN20100006

IND 114369

IND 118358

Pro00029638

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Emmes Company, LLC

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)