Summary

for people ages up to 21 years (full criteria)
at UCSDUCLA
study started
estimated completion
Jaime Deville (ucla)

Description

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).

Details

The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs administered to children per standard of care as prescribed by their treating caregiver. This will be accomplished by the collection of biological samples during the time of drug administration per standard of care as prescribed by the caregiver. The prescribing of drugs to children will not be part of this protocol.

Aim #1: Evaluate the PK of understudied drugs currently being administered to children.

Hypothesis #1: The PK of understudied drugs in children will differ from adults and within children according to pediatric age groups or special population.

Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered to children.

Hypothesis #2: The PD of targeted drugs in children will differ from adults.

Aim #3: Evaluate the influence of genetic factors, metabolic and protein profiles on therapeutic exposure.

Hypothesis #3: Genetic polymorphisms in drug metabolizing enzymes and metabolic and proteomic profiles will impact drug exposure in children.

Keywords

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 BleedingInsomniaanaestheticanticoagulantanti-epilepticanti-inflammatoryantimicrobialanti-psychoticantiviralanxiolyticheadachesherpes simplex virus (HSV)influenzalower respiratory tract infection (LRTI)meningitismuscle spasmsprophylaxisretinitissedativesepticemiaswellingurinary tract infectionurinary tract infection (UTI)empiric therapystaphylococcicontrol of serum phosphorusDiseaseCommunicable DiseasesKidney DiseasesRenal Insufficiency, ChronicHemorrhageMigraine DisordersSleep Initiation and Maintenance DisordersHemophilia AHeart ArrestFamilial Primary Pulmonary HypertensionRespiratory Tract InfectionsAdenoviridae InfectionsHerpes SimplexArrhythmias, CardiacHemangiomaIntraabdominal InfectionsMenorrhagiaHemangioma, CapillaryPort-Wine StainHealthcare-Associated PneumoniaToxemiaMeningitis, BacterialPotassium DeficiencySpasmTranexamic AcidAminocaproic AcidMethylprednisoloneCiprofloxacinPiperacillinPiperacillin, Tazobactam Drug CombinationSpironolactoneSevelamerThe POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:

Eligibility

You can join if…

Open to people ages up to 21 years

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

You CAN'T join if...

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

Locations

  • University of California at San Diego Medical Center in progress, not accepting new patients
    La JollaCalifornia92093United States
  • University of California, Los Angeles Medical Center accepting new patients
    Los AngelesCalifornia90095United States
  • Axis Clinical Trials terminated
    Los AngelesCalifornia90036United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daniel Benjamin
Links
Understudied Drugs Project Summary
ID
NCT01431326
Study Type
Observational
Last Updated