Clinical trial NCT05055830: Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Official title: Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Disease
Critically Ill
Children, Adult
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2021-09-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 21 years of age

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling
timeFrame: Data will be collected up to 180 days from the time of consent
measure: Half-life (t1/2) as measured by PK sampling
timeFrame: Data will be collected up to 180 days from the time of consent
measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling
timeFrame: Data will be collected up to 180 days from the time of consent
measure: AUC (area under the curve) as measured by PK sampling
timeFrame: Data will be collected up to 180 days from the time of consent
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke UMC
name: Christoph P Hornik, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: