Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Children (<21 years of age) who are prescribed drugs of interest Children and young adults who are prescribed drugs of interest as part of their routine medical care and are admitted to the pediatric cardiac intensive care unit |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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]
- Half-life (t1/2) as measured by PK sampling [Data will be collected up to 180 days from the time of consent]
- 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]
- AUC (area under the curve) as measured by PK sampling [Data will be collected up to 180 days from the time of consent]
Eligibility Criteria
Criteria
Inclusion Criteria:
To be eligible for enrollment, a potential participant must meet all the following criteria:
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Participant is <21 years old on admission
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Participant is admitted to the Pediatric Cardiac Intensive Care Unit
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Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent
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Participant is receiving one or more of the study drugs of interest at the time of enrollment
Exclusion Criteria:
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Duke University
- Food and Drug Administration (FDA)
Investigators
- Principal Investigator: Christoph P Hornik, MD, PhD, MPH, Duke UMC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00108566