Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

NCT01431326 | Completed DMC FDA Drug

• 10 other identifiers: Pro00029638IND 113645IND 114369IND 114531IND 118358HHSN20100006HHSN27500020HHSN27500027HHSN27500043HHSN27500049
• Study Type: observational
• Target: 3,520
• Locations: 5 countries
• Sites: 52

Brief Summary

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).

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

Keywords

adenovirus; anaesthetic; anesthesia; anticoagulant; anti-epileptic; anti-inflammatory; antimicrobial; anti-psychotic; antiviral; anxiety; anxiolysis; anxiolytic; autism; autistic disorder; benzodiazepine; bipolar disorder; convulsions; epilepsy; headaches; herpes simplex virus; herpes simplex virus (HSV); hypertension; infantile hemangioma; infection; inflammation; influenza; lower respiratory tract infection (LRTI); meningitis; migraines; muscle spasms; pain; pneumonia; prophylaxis; retinitis; schizophrenia; sedation; sedative; seizures; septicemia; swelling; urinary tract infection; urinary tract infection (UTI); withdrawal; empiric therapy; staphylococci; Fibrinolytic Bleeding; pulmonary arterial hypertension; CMV retinitis; control of serum phosphorus; Hyperaldosteronism; hypokalemia; heart failure; hemophilia; Heavy Menstrual Bleeding; insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Composite pharmacodynamic outcomes of understudied drugs in children

  Data will be collected throughout the hospital or outpatient stay up to 90 days

• Biomarkers associated with understudied drugs in children

  Data will be collected throughout the hospital or outpatient stay up to 90 days

Interventions

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

Also known as: cidofovir, ciprofloxacin, methylprednisolone, tobramycin, alfentanil, clozapine, haloperidol, lurasidone, molindone, pentobarbital, warfarin (oral), ziprasidone, amikacin, cefepime, nafcillin, piperacillin-tazobactam, rocuronium, vecuronium, vancomycin, aminocaproic acid, bosentan, fosfomycin, labetalol, nifedipine, oxycodone, sevelamer carbonate, spironolactone, tranexamic acid, zolpidem

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children (\<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver

You may qualify if:

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

You may not qualify if:

• \) Failure to obtain consent/assent (as indicated)
• \) Known pregnancy as determined via interview or testing if available.

Sponsors & Collaborators

• Daniel Benjamin: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (52)

Alaska Native Medical Center

Anchorage, Alaska, 99508, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

University of California at San Diego Medical Center

La Jolla, California, 92093, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

University of California, Los Angeles Medical Center

Los Angeles, California, 90095, United States

Location

The Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Yale New Haven Children's Hospital

New Haven, Connecticut, 06504, United States

Location

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida Jacksonville Shands Medical Center

Jacksonville, Florida, 32209, United States

Location

Kapiolani Womens and Childrens Medical Center

Honolulu, Hawaii, 96826, United States

Location

Lurie Children's Hospital of Chicago

Chicago, Illinois, 60614, United States

Location

Riley Hospital for Children at Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Fairway, Kansas, 66205, United States

Location

Children's Mercy Hospital and Clinics

Kansas City, Kansas, 66160, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Tulane University Health Science Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Baptist Clinical Trials Unit

New Orleans, Louisiana, 70115-6969, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

University of Montana

Missoula, Montana, 59804, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University of New Mexico, Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

UNC Hospital Neonatal-Perinatal Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center (PICU / NICU)

Durham, North Carolina, 27710, United States

Location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Akron Children's Hospital

Cleveland, Ohio, 44313, United States

Location

Board of Regents of the University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health and Science University

Portland, Oregon, 97201-2701, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of South Carolina

Columbia, South Carolina, 29203, United States

Location

University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84108, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

Location

University of Virginia Children's Hospital

Charlottesville, Virginia, 22908-0386, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Manitoba Institute of Child Health

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Hospital Sainte-Justine

Montreal, Quebec, T3T 1C5, Canada

Location

Assaf Harofeh Medical Center

Zerifin, Tel Aviv, 70300, Israel

Location

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

KK Women's and Children's Hospital Pte Ltd

Singapore, 229899, Singapore

Location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

Related Publications (23)

• 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: 24614374 RESULT

• 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: 24949994 RESULT

• 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: 26039810 RESULT

• 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: 27522443 RESULT

• 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: 26926644 RESULT

• 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: 29084742 RESULT

• 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: 29271816 RESULT

• 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: 29435949 RESULT

• 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: 29677389 RESULT

• 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: 30790601 RESULT

• 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.

  PMID: 31317556 RESULT

• Maharaj AR, Gonzalez D, Cohen-Wolkowiez M, Hornik CP, Edginton AN. Improving Pediatric Protein Binding Estimates: An Evaluation of alpha1-Acid Glycoprotein Maturation in Healthy and Infected Subjects. Clin Pharmacokinet. 2018 May;57(5):577-589. doi: 10.1007/s40262-017-0576-7.

  PMID: 28779462 RESULT

• Maharaj AR, Wu H, Zimmerman KO, Speicher DG, Sullivan JE, Watt K, Al-Uzri A, Payne EH, Erinjeri J, Lin S, Harper B, Melloni C, Hornik CP; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Dosing of Continuous Fentanyl Infusions in Obese Children: A Population Pharmacokinetic Analysis. J Clin Pharmacol. 2020 May;60(5):636-647. doi: 10.1002/jcph.1562. Epub 2019 Dec 8.

  PMID: 31814149 RESULT

• Thompson EJ, Wu H, Melloni C, Balevic S, Sullivan JE, Laughon M, Clark KM, Kalra R, Mendley S, Payne EH, Erinjeri J, Gelber CE, Harper B, Cohen-Wolkowiez M, Hornik CP; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Doxycycline in Children. Antimicrob Agents Chemother. 2019 Sep 9;63(12):e01508-19. doi: 10.1128/AAC.01508-19. Epub 2019 Sep 23.

  PMID: 31548185 RESULT

• Ge S, Mendley SR, Gerhart JG, Melloni C, Hornik CP, Sullivan JE, Atz A, Delmore P, Tremoulet A, Harper B, Payne E, Lin S, Erinjeri J, Cohen-Wolkowiez M, Gonzalez D; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Metoclopramide in Infants, Children, and Adolescents. Clin Transl Sci. 2020 Nov;13(6):1189-1198. doi: 10.1111/cts.12803. Epub 2020 May 27.

  PMID: 32324313 RESULT

• Maharaj AR, Wu H, Zimmerman KO, Autmizguine J, Kalra R, Al-Uzri A, Sherwin CMT, Goldstein SL, Watt K, Erinjeri J, Payne EH, Cohen-Wolkowiez M, Hornik CP. Population pharmacokinetics of olanzapine in children. Br J Clin Pharmacol. 2021 Feb;87(2):542-554. doi: 10.1111/bcp.14414. Epub 2020 Jul 5.

  PMID: 32497307 RESULT

• Commander SJ, Wu H, Boakye-Agyeman F, Melloni C, Hornik CD, Zimmerman K, Al-Uzri A, Mendley SR, Harper B, Cohen-Wolkowiez M, Hornik CP; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Pharmacokinetics of Hydrochlorothiazide in Children: A Potential Surrogate for Renal Secretion Maturation. J Clin Pharmacol. 2021 Mar;61(3):368-377. doi: 10.1002/jcph.1739. Epub 2020 Oct 7.

  PMID: 33029806 RESULT

• Wu YSS, Cohen-Wolkowiez M, Hornik CP, Gerhart JG, Autmizguine J, Cobbaert M, Gonzalez D; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. External Evaluation of Two Pediatric Population Pharmacokinetics Models of Oral Trimethoprim and Sulfamethoxazole. Antimicrob Agents Chemother. 2021 Jun 17;65(7):e0214920. doi: 10.1128/AAC.02149-20. Epub 2021 Jun 17.

  PMID: 33903114 RESULT

• Maharaj AR, Wu H, Zimmerman KO, Muller WJ, Sullivan JE, Sherwin CMT, Autmizguine J, Rathore MH, Hornik CD, Al-Uzri A, Payne EH, Benjamin DK Jr, Hornik CP; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Pharmacokinetics of Ceftazidime in Children and Adolescents with Obesity. Paediatr Drugs. 2021 Sep;23(5):499-513. doi: 10.1007/s40272-021-00460-4. Epub 2021 Jul 23.

  PMID: 34302290 RESULT

• Gerhart JG, Carreno FO, Ford JL, Edginton AN, Perrin EM, Watt KM, Muller WJ, Atz AM, Al-Uzri A, Delmore P, Gonzalez D; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Use of physiologically-based pharmacokinetic modeling to inform dosing of the opioid analgesics fentanyl and methadone in children with obesity. CPT Pharmacometrics Syst Pharmacol. 2022 Jun;11(6):778-791. doi: 10.1002/psp4.12793. Epub 2022 May 2.

  PMID: 35491971 RESULT

• Karatza E, Ganguly S, Hornik CD, Muller WJ, Al-Uzri A, James L, Balevic SJ, Gonzalez D. External Evaluation of Risperidone Population Pharmacokinetic Models Using Opportunistic Pediatric Data. Front Pharmacol. 2022 Mar 17;13:817276. doi: 10.3389/fphar.2022.817276. eCollection 2022.

  PMID: 35370711 RESULT

• Smith MJ, Gonzalez D, Goldman JL, Yogev R, Sullivan JE, Reed MD, Anand R, Martz K, Berezny K, Benjamin DK Jr, Smith PB, Cohen-Wolkowiez M, Watt K; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Pharmacokinetics of Clindamycin in Obese and Nonobese Children. Antimicrob Agents Chemother. 2017 Mar 24;61(4):e02014-16. doi: 10.1128/AAC.02014-16. Print 2017 Apr.

  PMID: 28137820 RESULT

• Hornik CP, Wu H, Edginton AN, Watt K, Cohen-Wolkowiez M, Gonzalez D. Development of a Pediatric Physiologically-Based Pharmacokinetic Model of Clindamycin Using Opportunistic Pharmacokinetic Data. Clin Pharmacokinet. 2017 Nov;56(11):1343-1353. doi: 10.1007/s40262-017-0525-5.

  PMID: 28290120 DERIVED

Related Links

• Understudied Drugs Project Summary

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Adenoviridae Infections; Anxiety Disorders; Autistic Disorder; Meningitis, Bacterial; Bipolar Disorder; Central Nervous System Infections; Seizures; Cytomegalovirus Retinitis; Epilepsy; Herpes Simplex; Hemangioma, Capillary; Infections; Inflammation; Intraabdominal Infections; Migraine Disorders; Pain; Pneumonia; Schizophrenia; Schizophrenia, Treatment-Resistant; Urinary Tract Infections; Sepsis; Bradycardia; Heart Arrest; Arrhythmias, Cardiac; Staphylococcal Infections; Healthcare-Associated Pneumonia; Endocarditis; Neutropenia; Headache; Pulmonary Arterial Hypertension; Hypertension; Renal Insufficiency, Chronic; Hyperaldosteronism; Hypokalemia; Heart Failure; Hemophilia A; Menorrhagia; Sleep Initiation and Maintenance Disorders; Influenza, Human; Meningitis; Spasm; Retinitis

Interventions

Cidofovir; Ciprofloxacin; Methylprednisolone; Tobramycin; Alfentanil; Clozapine; Haloperidol; Lurasidone Hydrochloride; Molindone; Pentobarbital; Warfarin; ziprasidone; Amikacin; Cefepime; Nafcillin; Piperacillin, Tazobactam Drug Combination; Rocuronium; Vecuronium Bromide; Vancomycin; Aminocaproic Acid; Bosentan; Fosfomycin; Labetalol; Nifedipine; Oxycodone; Sevelamer; Spironolactone; Tranexamic Acid; Zolpidem

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Bipolar and Related Disorders; Mood Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Infections, Viral; Eye Infections; Cytomegalovirus Infections; Herpesviridae Infections; Eye Diseases; Retinal Diseases; Brain Diseases; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Headache Disorders, Primary; Headache Disorders; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Systemic Inflammatory Response Syndrome; Heart Diseases; Cardiovascular Diseases; Gram-Positive Bacterial Infections; Cross Infection; Iatrogenic Disease; Disease Attributes; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Hypertension, Pulmonary; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Chronic Disease; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Hemorrhage; Menstruation Disturbances; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Orthomyxoviridae Infections; RNA Virus Infections; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Fentanyl; Piperidines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Butyrophenones; Ketones; Thiazoles; Sulfur Compounds; Azoles; Isoindoles; Indoles; Barbiturates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Penicillins; Tazobactam; Penicillanic Acid; Piperacillin; Ampicillin; Penicillin G; Sulfones; Drug Combinations; Pharmaceutical Preparations; Androstanols; Androstanes; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ethanolamines; Amino Alcohols; Alcohols; Salicylamides; Amines; Dihydropyridines; Pyridines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polyamines; Lactones; Pregnenes; Cyclohexanecarboxylic Acids; Acids, Carbocyclic

Study Officials

• Chi Hornik, PharmD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: September 9, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); US (43); SG (1); GB (2); CA (4)