NCT05055830

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

Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 0 Months – 20 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-10-05
• Primary completion: 2027-10-30
• Completion: 2028-10-30
• First posted: 2021-09-24
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States