Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-20
SponsorDuke University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Participant is <21 years old on admission
Participant is admitted to the Pediatric Cardiac Intensive Care Unit
Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent
Participant is receiving one or more of the study drugs of interest at the time of enrollment
Disqualifiers
None
Trial population
Children under 21 years of age
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.
DrugThe 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.
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Children (<21 years of age) who are prescribed drugs of interest1 intervention
Trial outcomes
Primary outcomes
1
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 consent2
Half-life (t1/2) as measured by PK sampling
Time frame
Data will be collected up to 180 days from the time of consent3
Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling
Time frame
Data will be collected up to 180 days from the time of consent4
AUC (area under the curve) as measured by PK sampling
Time frame
Data will be collected up to 180 days from the time of consentSponsors and contacts
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Duke University
Lead sponsor
Food and Drug Administration (FDA)
Collaborator
Source ClinicalTrials.gov