Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

CompletedOBSERVATIONAL
Enrollment

3,520

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

November 30, 2019

Study Completion Date

November 30, 2019

Conditions
AdenovirusAnesthesiaAnxietyAnxiolysisAutismAutistic DisorderBacterial MeningitisBacterial SepticemiaBenzodiazepineBipolar DisorderBone and Joint InfectionsCentral Nervous System InfectionsConvulsionsCytomegalovirus RetinitisEarly-onset Schizophrenia Spectrum DisordersEpilepsyGeneral AnesthesiaGynecologic InfectionsHerpes Simplex VirusInfantile HemangiomaInfectionInflammationInflammatory ConditionsIntra-abdominal InfectionsLower Respiratory Tract InfectionsMigrainesPainPneumoniaSchizophreniaSedationSeizuresSkeletal Muscle SpasmsSkin and Skin-structure InfectionsTreatment-resistant SchizophreniaUrinary Tract InfectionsWithdrawalSepsisGram-negative InfectionBradycardiaCardiac ArrestCardiac ArrhythmiaStaphylococcal InfectionsNosocomial PneumoniaNeuromuscular BlockadeMethicillin Resistant Staphylococcus AureusEndocarditisNeutropeniaHeadacheFibrinolytic BleedingPulmonary Arterial HypertensionCMV RetinitisHypertensionChronic Kidney DiseasesHyperaldosteronismHypokalemiaHeart FailureHemophiliaHeavy Menstrual BleedingInsomnia
Interventions
DRUG

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

Trial Locations (52)

19803

Alfred I. DuPont Hospital for Children, Wilmington

20010

Children's National Medical Center, Washington D.C.

21201

University of Maryland, Baltimore

26506

West Virginia University Hospital, Morgantown

27599

UNC Hospital Neonatal-Perinatal Medicine, Chapel Hill

27710

Duke University Medical Center (PICU / NICU), Durham

29203

University of South Carolina, Columbia

29425

Medical University of South Carolina, Charleston

32209

University of Florida Jacksonville Shands Medical Center, Jacksonville

39216

University of Mississippi Medical Center, Jackson

40202

Norton Children's Hospital, Louisville

44106

Rainbow Babies and Children's Hospital, Cleveland

44313

Akron Children's Hospital, Cleveland

46202

Riley Hospital for Children at Indiana University, Indianapolis

48201

Children's Hospital of Michigan, Detroit

49202

Schneider Children's Medical Center of Israel, Petah Tikva

53226

Medical College of Wisconsin, Milwaukee

59804

University of Montana, Missoula

60614

Lurie Children's Hospital of Chicago, Chicago

64108

Children's Mercy Hospitals and Clinics, Kansas City

66160

Children's Mercy Hospital and Clinics, Kansas City

66205

University of Kansas Medical Center, Fairway

67214

Wesley Medical Center, Wichita

68198

University of Nebraska Medical Center, Omaha

70112

Tulane University Health Science Center, New Orleans

70300

Assaf Harofeh Medical Center, Zerifin

72202

Arkansas Children's Hospital, Little Rock

73104

Board of Regents of the University of Oklahoma, Oklahoma City

80045

The Children's Hospital Colorado, Aurora

84108

University of Utah Hospitals and Clinics, Salt Lake City

87131

University of New Mexico, Health Sciences Center, Albuquerque

90036

Axis Clinical Trials, Los Angeles

90095

University of California, Los Angeles Medical Center, Los Angeles

92093

University of California at San Diego Medical Center, La Jolla

96826

Kapiolani Womens and Childrens Medical Center, Honolulu

98105

Seattle Children's Hospital, Seattle

99508

Alaska Native Medical Center, Anchorage

229899

KK Women's and Children's Hospital Pte Ltd, Singapore

06504

Yale New Haven Children's Hospital, New Haven

70115-6969

Ochsner Baptist Clinical Trials Unit, New Orleans

03756

Dartmouth-Hitchcock Medical Center, Lebanon

45229-3039

Cincinnati Childrens Hospital Medical Center, Cincinnati

97201-2701

Oregon Health and Science University, Portland

02903

Rhode Island Hospital, Providence

05405

University of Vermont Medical Center, Burlington

22908-0386

University of Virginia Children's Hospital, Charlottesville

R3E 3P4

Manitoba Institute of Child Health, Winnipeg

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

The Hospital for Sick Children, Toronto

T3T 1C5

Hospital Sainte-Justine, Montreal

SO16 6YD

Southampton General Hospital, Southampton

L12 2AP

Alder Hey Children's Hospital, Liverpool

All Listed Sponsors
collaborator

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

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

lead

Daniel Benjamin

OTHER

NCT01431326 - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care | Biotech Hunter | Biotech Hunter