Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Public ClinicalTrials.gov record NCT01431326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
Study identification
- NCT ID
- NCT01431326
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 3,520 participants
Conditions and interventions
Conditions
- Adenovirus
- Anesthesia
- Anxiety
- Anxiolysis
- Autism
- Autistic Disorder
- Bacterial Meningitis
- Bacterial Septicemia
- Benzodiazepine
- Bipolar Disorder
- Bone and Joint Infections
- Central Nervous System Infections
- Convulsions
- Cytomegalovirus Retinitis
- Early-onset Schizophrenia Spectrum Disorders
- Epilepsy
- General Anesthesia
- Gynecologic Infections
- Herpes Simplex Virus
- Infantile Hemangioma
- Infection
- Inflammation
- Inflammatory Conditions
- Intra-abdominal Infections
- Lower Respiratory Tract Infections
- Migraines
- Pain
- Pneumonia
- Schizophrenia
- Sedation
- Seizures
- Skeletal Muscle Spasms
- Skin and Skin-structure Infections
- Treatment-resistant Schizophrenia
- Urinary Tract Infections
- Withdrawal
- Sepsis
- Gram-negative Infection
- Bradycardia
- Cardiac Arrest
- Cardiac Arrhythmia
- Staphylococcal Infections
- Nosocomial Pneumonia
- Neuromuscular Blockade
- Methicillin Resistant Staphylococcus Aureus
- Endocarditis
- Neutropenia
- Headache
- Fibrinolytic Bleeding
- Pulmonary Arterial Hypertension
- CMV Retinitis
- Hypertension
- Chronic Kidney Diseases
- Hyperaldosteronism
- Hypokalemia
- Heart Failure
- Hemophilia
- Heavy Menstrual Bleeding
- Insomnia
Eligibility (public fields only)
- Age range
- Up to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2011 (Actual)
- Primary completion
- Nov 2019 (Actual)
- Completion
- Nov 2019 (Actual)
- Last update posted
- Sep 6, 2023
2011 – 2019
United States locations
- U.S. sites
- 43
- U.S. states
- 34
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Native Medical Center | Anchorage | Alaska | 99508 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| University of California at San Diego Medical Center | La Jolla | California | 92093 | — |
| Axis Clinical Trials | Los Angeles | California | 90036 | — |
| University of California, Los Angeles Medical Center | Los Angeles | California | 90095 | — |
| The Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Yale New Haven Children's Hospital | New Haven | Connecticut | 06504 | — |
| Alfred I. DuPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida Jacksonville Shands Medical Center | Jacksonville | Florida | 32209 | — |
| Kapiolani Womens and Childrens Medical Center | Honolulu | Hawaii | 96826 | — |
| Lurie Children's Hospital of Chicago | Chicago | Illinois | 60614 | — |
| Riley Hospital for Children at Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center | Fairway | Kansas | 66205 | — |
| Children's Mercy Hospital and Clinics | Kansas City | Kansas | 66160 | — |
| Wesley Medical Center | Wichita | Kansas | 67214 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Tulane University Health Science Center | New Orleans | Louisiana | 70112 | — |
| Ochsner Baptist Clinical Trials Unit | New Orleans | Louisiana | 70115-6969 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| University of Montana | Missoula | Montana | 59804 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| University of New Mexico, Health Sciences Center | Albuquerque | New Mexico | 87131 | — |
| UNC Hospital Neonatal-Perinatal Medicine | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center (PICU / NICU) | Durham | North Carolina | 27710 | — |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Akron Children's Hospital | Cleveland | Ohio | 44313 | — |
| Board of Regents of the University of Oklahoma | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health and Science University | Portland | Oregon | 97201-2701 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of South Carolina | Columbia | South Carolina | 29203 | — |
| University of Utah Hospitals and Clinics | Salt Lake City | Utah | 84108 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05405 | — |
| University of Virginia Children's Hospital | Charlottesville | Virginia | 22908-0386 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01431326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 6, 2023 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01431326 live on ClinicalTrials.gov.