Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05055830
Status
Recruiting
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Conditions

  • Cardiac Disease
  • Children, Adult
  • Critically Ill

Eligibility Criteria

Sex
ALL
Age
0 Months - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care. — DRUG
    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.

Study Details

OPTIC is a prospective, open-label, non-randomized study of multiple medications administered to approximately 2000 children in the pediatric cardiac intensive care unit (PCICU) per routine clinical car by their treating provider. The purpose of this study is to characterize the PK of drugs routinely administered to children per standard of care using opportunistic and scavenged samples. The prescribing of drugs to children will not be part of this protocol. After the child/adult (\<21 years of age) is consented/enrolled, demographic and clinical data will be extracted from the EHR. Biospecimen information (including date and time of sample collection) will be collected. Data analysis will be conducted on all participants with at least 2 evaluable samples. The protocol represents minimal risk to the children/adults who provide body fluid for this study, including potential loss of confidentiality (samples will be assigned a unique accession number) and risks associated with blood draws. Adverse Events (AEs)/Serious Adverse Events (SAEs) caused by the study specimen collections will be monitored and recorded in the Electronic Data Capture (EDC) system.

Key Dates

Start date
Oct 5, 2021
Status verified
Nov 2025
Primary completion
Oct 30, 2027
Completion
Oct 30, 2028

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Children (<21 years of age) who are prescribed drugs of interest
    Children and young adults who are prescribed drugs of interest as part of their routine medical care and are admitted to the pediatric cardiac intensive care unit

Primary Outcome Measure

Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling [ Time Frame: Data will be collected up to 180 days from the time of consent ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27705
Liz Thompson, MD

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By research site
Duke University Medical Center· Durham, NC

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