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

Cardiac Disease Clinical Trial

— OPTIC  

Official title:

Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05055830
• Other study ID #: Pro00108566
• Status: Recruiting
• Start date: October 5, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2023
• Source: Duke University
• Contact: Stefany Olague, MPH
• Phone: 9196688131
• Email: smalltrials-CRC[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 20 Years

Eligibility

Inclusion Criteria:

To be eligible for enrollment, a potential participant must meet all the following criteria:

1. Participant is <21 years old on admission

2. Participant is admitted to the Pediatric Cardiac Intensive Care Unit

3. Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent

4. Participant is receiving one or more of the study drugs of interest at the time of enrollment

Exclusion Criteria:

1. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Related Conditions & MeSH terms

• Cardiac Disease
• Children, Adult
• Critical Illness
• Critically Ill
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling		Data will be collected up to 180 days from the time of consent
Primary	Half-life (t1/2) as measured by PK sampling		Data will be collected up to 180 days from the time of consent
Primary	Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling		Data will be collected up to 180 days from the time of consent
Primary	AUC (area under the curve) as measured by PK sampling		Data will be collected up to 180 days from the time of consent