Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
NCT ID: NCT05055830
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2021-10-05
2028-10-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion 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
0 Months
20 Years
ALL
No
Sponsors
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Food and Drug Administration (FDA)
FED
Duke University
OTHER
Responsible Party
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Principal Investigators
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Christoph P Hornik, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Duke UMC
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Liz Thompson, MD
Role: primary
References
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Thompson EJ, Foote HP, Hill KD, Hornik CP. A point-of-care pharmacokinetic/pharmacodynamic trial in critically ill children: Study design and feasibility. Contemp Clin Trials Commun. 2023 Jul 7;35:101182. doi: 10.1016/j.conctc.2023.101182. eCollection 2023 Oct.
Other Identifiers
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Pro00108566
Identifier Type: -
Identifier Source: org_study_id