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Clinical Trial Details

Trial ID: L1768
Source ID: NCT01431326
Associated Drug: The Pops Study Is Collecting Pk Data On Children Prescribed The Following Drugs Of Interest Per Standard Of Care:
Title: Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Acronym: PTN_POPS
Status: COMPLETED
Study Results: NO
Results:
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
Interventions: DRUG: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
Outcome Measures: Primary: Composite of pharmacokinetic outcomes for understudied drugs in children, As appropriate for each study drug, the following additional PK parameters will be estimated: * maximum concentration (Cmax) * time to achieve maximum concentration (Tmax) * absorption rate constant (ka) * elimination rate constant (kel) * half-life (t1/2) * area under the curve (AUC) Penetration into body fluids will be determined by comparing exposure (i.e. AUC, Cmax) ratios between the body fluid and plasma or comparison of concentrations in paired samples., Data will be collected throughout the hospital or outpatient stay up to 90 days | Secondary: Composite pharmacodynamic outcomes of understudied drugs in children, When applicable, Monte Carlo simulations will be performed to evaluate therapeutic target attainment rates (pharmacodynamics) in the population of interest. The final PK model and parameters estimated in the population PK analysis will be used to perform these simulations., Data will be collected throughout the hospital or outpatient stay up to 90 days|Biomarkers associated with understudied drugs in children, The dosing, sampling, and demographic information recorded on the electronic data collection forms will be merged with the bioanalytical information to create a biomarker dataset for each study drug. Biomarkers will be identified using metabolomics/proteomics and pharmacogenomics methodologies. Samples for biomarker analysis will be stored for future use in a PTN designated biorepository. Associations between biomarkers and drug exposure will be explored by visual inspection (i.e. scatter plots) and statistical comparisons as needed., Data will be collected throughout the hospital or outpatient stay up to 90 days
Sponsor/Collaborators: Sponsor: Daniel Benjamin | Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|The Emmes Company, LLC
Gender: ALL
Age: CHILD, ADULT
Phases:
Enrollment: 3520
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2011-11
Completion Date: 2019-11
Results First Posted:
Last Update Posted: 2023-09-06
Locations: Alaska Native Medical Center, Anchorage, Alaska, 99508, United States|Arkansas Children's Hospital, Little Rock, Arkansas, 72202, United States|University of California at San Diego Medical Center, La Jolla, California, 92093, United States|Axis Clinical Trials, Los Angeles, California, 90036, United States|University of California, Los Angeles Medical Center, Los Angeles, California, 90095, United States|The Children's Hospital Colorado, Aurora, Colorado, 80045, United States|Yale New Haven Children's Hospital, New Haven, Connecticut, 06504, United States|Alfred I. DuPont Hospital for Children, Wilmington, Delaware, 19803, United States|Children's National Medical Center, Washington, District of Columbia, 20010, United States|University of Florida Jacksonville Shands Medical Center, Jacksonville, Florida, 32209, United States|Kapiolani Womens and Childrens Medical Center, Honolulu, Hawaii, 96826, United States|Lurie Children's Hospital of Chicago, Chicago, Illinois, 60614, United States|Riley Hospital for Children at Indiana University, Indianapolis, Indiana, 46202, United States|University of Kansas Medical Center, Fairway, Kansas, 66205, United States|Children's Mercy Hospital and Clinics, Kansas City, Kansas, 66160, United States|Wesley Medical Center, Wichita, Kansas, 67214, United States|Norton Children's Hospital, Louisville, Kentucky, 40202, United States|Tulane University Health Science Center, New Orleans, Louisiana, 70112, United States|Ochsner Baptist Clinical Trials Unit, New Orleans, Louisiana, 70115-6969, United States|University of Maryland, Baltimore, Maryland, 21201, United States|Children's Hospital of Michigan, Detroit, Michigan, 48201, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Children's Mercy Hospitals and Clinics, Kansas City, Missouri, 64108, United States|University of Montana, Missoula, Montana, 59804, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States|University of New Mexico, Health Sciences Center, Albuquerque, New Mexico, 87131, United States|UNC Hospital Neonatal-Perinatal Medicine, Chapel Hill, North Carolina, 27599, United States|Duke University Medical Center (PICU / NICU), Durham, North Carolina, 27710, United States|Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, 45229-3039, United States|Rainbow Babies and Children's Hospital, Cleveland, Ohio, 44106, United States|Akron Children's Hospital, Cleveland, Ohio, 44313, United States|Board of Regents of the University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States|Oregon Health and Science University, Portland, Oregon, 97201-2701, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|University of South Carolina, Columbia, South Carolina, 29203, United States|University of Utah Hospitals and Clinics, Salt Lake City, Utah, 84108, United States|University of Vermont Medical Center, Burlington, Vermont, 05405, United States|University of Virginia Children's Hospital, Charlottesville, Virginia, 22908-0386, United States|Seattle Children's Hospital, Seattle, Washington, 98105, United States|West Virginia University Hospital, Morgantown, West Virginia, 26506, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|Manitoba Institute of Child Health, Winnipeg, Manitoba, R3E 3P4, Canada|Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada|The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|Hospital Sainte-Justine, Montreal, Quebec, T3T 1C5, Canada|Assaf Harofeh Medical Center, Zerifin, Tel Aviv, 70300, Israel|Schneider Children's Medical Center of Israel, Petah Tikva, 49202, Israel|KK Women's and Children's Hospital Pte Ltd, Singapore, 229899, Singapore|Southampton General Hospital, Southampton, Hampshire, SO16 6YD, United Kingdom|Alder Hey Children's Hospital, Liverpool, Merseyside, L12 2AP, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01431326

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D130 Montelukast small molecule DB00471 Details