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

NCT05055830 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-11-14

No results posted yet for this study

Summary

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.

Conditions

  • Cardiac Disease
  • Critically Ill
  • Children, Adult

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Duke University

    lead OTHER

Principal Investigators

  • Christoph P Hornik, MD, PhD, MPH · Duke UMC

Eligibility

Min Age
0 Months
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2027-10-30
Completion
2028-10-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05055830 on ClinicalTrials.gov