Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 9:23 AM
Study NCT ID:
NCT04278404
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2020-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D054559', 'term': 'Hyperphosphatemia'}, {'id': 'D006929', 'term': 'Hyperaldosteronism'}, {'id': 'D004487', 'term': 'Edema'}, {'id': 'D007008', 'term': 'Hypokalemia'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D002481', 'term': 'Cellulitis'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D000309', 'term': 'Adrenal Insufficiency'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'C000705967', 'term': 'pediatric multisystem inflammatory disease, COVID-19 related'}, {'id': 'D009080', 'term': 'Mucocutaneous Lymph Node Syndrome'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015119', 'term': 'Aminocaproic Acid'}, {'id': 'D000638', 'term': 'Amiodarone'}, {'id': 'D000077300', 'term': 'Bosentan'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000077525', 'term': 'Cefdinir'}, {'id': 'D000077723', 'term': 'Cefepime'}, {'id': 'D002442', 'term': 'Ceftazidime'}, {'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D000078306', 'term': 'Clobazam'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'C449521', 'term': 'SLI381'}, {'id': 'D005578', 'term': 'Fosfomycin'}, {'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D016316', 'term': 'Guanfacine'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D007741', 'term': 'Labetalol'}, {'id': 'D000077731', 'term': 'Meropenem'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D020105', 'term': 'Milrinone'}, {'id': 'D009266', 'term': 'Nalbuphine'}, {'id': 'D009529', 'term': 'Nicardipine'}, {'id': 'D009543', 'term': 'Nifedipine'}, {'id': 'D053139', 'term': 'Oseltamivir'}, {'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D000069603', 'term': 'Sevelamer'}, {'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D013726', 'term': 'Terbutaline'}, {'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D065819', 'term': 'Voriconazole'}, {'id': 'D000077334', 'term': 'Zolpidem'}, {'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D053590', 'term': 'Interleukin 1 Receptor Antagonist Protein'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'C541220', 'term': 'canakinumab'}, {'id': 'D003078', 'term': 'Colchicine'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'C000606551', 'term': 'remdesivir'}, {'id': 'C540383', 'term': 'ruxolitinib'}, {'id': 'C000592401', 'term': 'sarilumab'}, {'id': 'D000069594', 'term': 'Abatacept'}, {'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D000614', 'term': 'Aminocaproates'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D002509', 'term': 'Cephaloridine'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D012457', 'term': 'Salicylamides'}, {'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D000676', 'term': 'Amrinone'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D007162', 'term': 'Immunoproteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, effluent samples, and plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling', 'timeFrame': 'Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.'}, {'measure': 'Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling', 'timeFrame': 'Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.'}, {'measure': 'Elimination rate constant (ke) as measured by PK sampling', 'timeFrame': 'Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.'}, {'measure': 'Half-life (t1/2) as measured by PK sampling', 'timeFrame': 'Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.'}, {'measure': 'Absorption rate constant (ka) as measured by PK sampling', 'timeFrame': 'Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.'}, {'measure': 'AUC (area under the curve) as measured by PK sampling', 'timeFrame': 'Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.'}, {'measure': 'Maximum concentration (Cmax) as measured by PK sampling', 'timeFrame': 'Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.'}, {'measure': 'Time to achieve maximum concentration (Tmax) as measured by PK sampling', 'timeFrame': 'Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Infection (COVID-19)', 'Pulmonary Arterial Hypertension', 'Urinary Tract Infections in Children', 'Hypertension', 'Pain', 'Hyperphosphatemia', 'Primary Hyperaldosteronism', 'Edema', 'Hypokalemia', 'Heart Failure', 'Hemophilia', 'Menorrhagia', 'Insomnia', 'Pneumonia', 'Skin Infection', 'Arrythmia', 'Asthma in Children', 'Bronchopulmonary Dysplasia', 'Adrenal Insufficiency', 'Fibrinolysis; Hemorrhage', 'Attention Deficit Hyperactivity Disorder', 'Multisystem Inflammatory Syndrome in Children (MIS-C)', 'Kawasaki Disease', 'Coagulation Disorder', 'Down Syndrome']}, 'referencesModule': {'references': [{'pmid': '24614374', 'type': 'BACKGROUND', 'citation': 'Tremoulet A, Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Salgado A, Ian-U Chong S, Melloni C, Gao J, Benjamin DK Jr, Capparelli EV, Cohen-Wolkowiez M; Administrative Core Committee of the Best Pharmaceuticals for Children Act-Pediatric Trials Network. Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design. Antimicrob Agents Chemother. 2014 Jun;58(6):3013-20. doi: 10.1128/AAC.02374-13. Epub 2014 Mar 10.'}, {'pmid': '27522443', 'type': 'BACKGROUND', 'citation': 'Hornik CP, Benjamin DK Jr, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, Ericson JE, Clark RH, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network. Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates. J Pediatr. 2016 Nov;178:125-129.e1. doi: 10.1016/j.jpeds.2016.07.011. Epub 2016 Aug 10.'}, {'pmid': '29271816', 'type': 'BACKGROUND', 'citation': 'Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Blackford M, Yogev R, James LP, Melloni C, Harper B, Mitchell J, Benjamin DK Jr, Boakye-Agyeman F, Cohen-Wolkowiez M. Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates. Ther Drug Monit. 2018 Feb;40(1):103-108. doi: 10.1097/FTD.0000000000000466.'}, {'pmid': '24949994', 'type': 'BACKGROUND', 'citation': 'Gonzalez D, Melloni C, Yogev R, Poindexter BB, Mendley SR, Delmore P, Sullivan JE, Autmizguine J, Lewandowski A, Harper B, Watt KM, Lewis KC, Capparelli EV, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Administrative Core Committee. Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents. Clin Pharmacol Ther. 2014 Oct;96(4):429-37. doi: 10.1038/clpt.2014.134. Epub 2014 Jun 20.'}, {'pmid': '26926644', 'type': 'BACKGROUND', 'citation': 'Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK Jr, Laughon MM. Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2888-94. doi: 10.1128/AAC.03086-15. Print 2016 May.'}, {'pmid': '26039810', 'type': 'BACKGROUND', 'citation': 'Gonzalez D, Melloni C, Poindexter BB, Yogev R, Atz AM, Sullivan JE, Mendley SR, Delmore P, Delinsky A, Zimmerman K, Lewandowski A, Harper B, Lewis KC, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act--Pediatric Trials Network Administrative Core Committee. Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots. Bioanalysis. 2015;7(9):1137-49. doi: 10.4155/bio.15.38.'}, {'pmid': '29084742', 'type': 'BACKGROUND', 'citation': 'Autmizguine J, Melloni C, Hornik CP, Dallefeld S, Harper B, Yogev R, Sullivan JE, Atz AM, Al-Uzri A, Mendley S, Poindexter B, Mitchell J, Lewandowski A, Delmore P, Cohen-Wolkowiez M, Gonzalez D; the Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Trimethoprim-Sulfamethoxazole in Infants and Children. Antimicrob Agents Chemother. 2017 Dec 21;62(1):e01813-17. doi: 10.1128/AAC.01813-17. Print 2018 Jan.'}, {'pmid': '29435949', 'type': 'BACKGROUND', 'citation': 'Dallefeld SH, Atz AM, Yogev R, Sullivan JE, Al-Uzri A, Mendley SR, Laughon M, Hornik CP, Melloni C, Harper B, Lewandowski A, Mitchell J, Wu H, Green TP, Cohen-Wolkowiez M. A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):419-430. doi: 10.1007/s10928-018-9576-y. Epub 2018 Feb 12.'}, {'pmid': '29677389', 'type': 'BACKGROUND', 'citation': 'Hornik CP, Gonzalez D, van den Anker J, Atz AM, Yogev R, Poindexter BB, Ng KC, Delmore P, Harper BL, Melloni C, Lewandowski A, Gelber C, Cohen-Wolkowiez M, Lee JH; Pediatric Trial Network Steering Committee. Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children. J Clin Pharmacol. 2018 Aug;58(8):1092-1104. doi: 10.1002/jcph.1116. Epub 2018 Apr 20.'}, {'pmid': '30790601', 'type': 'BACKGROUND', 'citation': 'Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C; Pediatric Trials Network Steering Committee (See Acknowledgments for a listing of committee members.). Systemic timolol exposure following topical application to infantile hemangiomas. J Am Acad Dermatol. 2020 Mar;82(3):733-736. doi: 10.1016/j.jaad.2019.02.029. Epub 2019 Feb 18. No abstract available.'}, {'pmid': '31317556', 'type': 'BACKGROUND', 'citation': 'Hornik CP, Yogev R, Mourani PM, Watt KM, Sullivan JE, Atz AM, Speicher D, Al-Uzri A, Adu-Darko M, Payne EH, Gelber CE, Lin S, Harper B, Melloni C, Cohen-Wolkowiez M, Gonzalez D; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Milrinone in Infants, Children, and Adolescents. J Clin Pharmacol. 2019 Dec;59(12):1606-1619. doi: 10.1002/jcph.1499. Epub 2019 Jul 17.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/media/90358/download', 'label': 'Food and Drug Administration. General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products'}, {'url': 'https://www.elso.org/Registry/Statistics/InternationalSummary.aspx', 'label': 'Extracorporeal Life Support Organization (ELSO). ECLS Registry Report: International Summary Ann Arbor, MI: Extracorporeal Life Support Organization (ELSO); 2020'}, {'url': 'https://pdfs.semanticscholar.org/b0d9/11f1f38ad7a83694bbee99fd41ae3db5b07d.pdf', 'label': 'Wildschut E, editor. Drug therapies in neonates and children during extracorporeal membrane oxygenation (ECMO); Keep your eyes open. Rotterdam, The Netherlands: Erasmus MC; 2010.'}]}, 'descriptionModule': {'briefSummary': 'The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children under 21 years of age.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant is \\< 21 years of age\n2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n Below exclusion criteria apply only to:\n\n Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study'}, 'identificationModule': {'nctId': 'NCT04278404', 'acronym': 'POPS or POP02', 'briefTitle': 'Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs', 'orgStudyIdInfo': {'id': 'Pro00103838'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children and young adults who are prescribed drugs of interest', 'description': 'Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.', 'interventionNames': ['Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:']}], 'interventions': [{'name': 'The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:', 'type': 'DRUG', 'otherNames': ['Aminocaproic acid', 'Amiodarone', 'Bosentan', 'Budesonide', 'Cefdinir', 'Cefepime', 'Ceftazidime', 'Clindamycin', 'Clobazam', 'Dexamethasone', 'Dexmedetomidine', 'Dextroamphetamine/Amphetamine', 'Fosfomycin', 'Furosemide', 'Gabapentin', 'Guanfacine', 'Hydrocortisone', 'Labetalol', 'Meropenem', 'Metformin', 'Milrinone', 'Nalbuphine', 'Nicardipine', 'Nifedipine', 'Oseltamivir', 'Oxycodone', 'Risperidone', 'Sertraline', 'Sevelamer Carbonate / Sevelamer Hydrochloride', 'Spironolactone', 'Terbutaline', 'Tranexamic acid', 'Voriconazole', 'Zolpidem', 'Azithromycin', 'Lopinavir/Ritonavir', 'Ribavirin', 'Tocilizumab', 'Anakinra', 'Aspirin', 'Canakinumab', 'Colchicine', 'Interferon', 'Remdesivir', 'Ruxolitinib', 'Sarilumab', 'Abatacept', 'Infliximab'], 'description': 'The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.', 'armGroupLabels': ['Children and young adults who are prescribed drugs of interest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Haley Spradin', 'role': 'CONTACT', 'email': 'spradlinhe@archildrens.org', 'phone': '501-364-5023'}, {'name': 'Lee Howard', 'role': 'CONTACT', 'email': 'howardle@archildrens.org', 'phone': '501-364-6990'}, {'name': 'Laura James', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Arkansas Children's Hospital Research Institute", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Carter', 'role': 'CONTACT', 'email': 'mfcarter@mednet.ucla.edu', 'phone': '310-206-6369'}, {'name': 'Yun Yong Margarida Lei', 'role': 'CONTACT', 'email': 'ylei@mednet.ucla.edu', 'phone': '310-206-2439'}, {'name': 'Jaime Deville', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yasaman Nourkhala', 'role': 'CONTACT', 'email': 'yasinour@stanford.edu', 'phone': '650-724-4548'}, {'name': 'Shelby Burk', 'role': 'CONTACT', 'email': 'shelbyb@stanford.edu', 'phone': '650-704-2186'}, {'name': 'Eunice Koh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Lucile Packard Children's Hospital", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lexi Petruccelli', 'role': 'CONTACT', 'email': 'lexi.petruccelli@childrenscolorado.org', 'phone': '720-777-9881'}, {'name': 'Aline Maddux', 'role': 'CONTACT', 'email': 'aline.maddux@childrenscolorado.org'}, {'name': 'Aline Maddux', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Colorado University Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Bernstein', 'role': 'CONTACT', 'email': 'rebecca.bernstein@childrenscolorado.org', 'phone': '720-777-2714'}, {'name': 'Kristine Wolter-Warmerd', 'role': 'CONTACT', 'email': 'kristine.wolter-warmerdam@childrenscolorado.org', 'phone': '507-319-9808'}, {'name': 'Elise Sannar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Alfred I. 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'02421', 'city': 'Lexington', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heli Patel', 'role': 'CONTACT', 'email': 'hpatel24@mgh.harvard.edu', 'phone': '781-860-1784'}, {'name': 'Alexander Cordova', 'role': 'CONTACT', 'email': 'acordova1@mgh.harvard.edu', 'phone': '1-781-860-1784'}, {'name': 'Michelle Palumbo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.44732, 'lon': -71.2245}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Fratesi', 'role': 'CONTACT', 'email': 'ekfratesi@umc.edu', 'phone': '601-815-4179'}, {'name': 'Taylor Fry', 'role': 'CONTACT', 'email': 'tfry@umc.edu', 'phone': '601-815-4180'}, {'name': 'Joseph Majure', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '39110', 'city': 'Madison', 'state': 'Mississippi', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Mississippi Center for Advanced Medicine', 'geoPoint': {'lat': 32.46181, 'lon': -90.11536}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joann Von Bonn', 'role': 'CONTACT', 'email': 'jvonbon@unmc.edu', 'phone': '402-836-9756'}, {'name': 'Rachel Wellman', 'role': 'CONTACT', 'email': 'rachel.wellman@unmc.edu', 'phone': '402-253-9176'}, {'name': 'Russell McCulloh', 'role': 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'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Harward', 'role': 'CONTACT', 'email': 'melissa.harward@dm.duke.edu', 'phone': '919-668-3910'}, {'name': 'Bethany Kristler', 'role': 'CONTACT', 'email': 'bethany.kistler@duke.edu', 'phone': '919-681-2554'}, {'name': 'Chi Hornik', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aine Powell', 'role': 'CONTACT', 'email': 'aine.powell@cchmc.org', 'phone': '513-636-0674'}, {'name': 'kellie Voth', 'role': 'CONTACT', 'email': 'kellie.ramsdale@cchmc.org', 'phone': '513-636-0674'}, {'name': 'Anna Esbensen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tonya Froehlich', 'role': 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