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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HD091365 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model and a single optimally timed PK sample, to predict vancomycin area under the curve (AUC) in critically ill children.
Opt Vanc is an observational study of critically ill children prescribed IV vancomycin for a suspected infection at the Children's Hospital of Philadelphia. This study will evaluate how well Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model for vancomycin and a single optimally timed vancomycin concentration, can predict vancomycin area under the curve (AUC) in critically ill children. Eligible subjects will be prescribed vancomycin and undergo routine therapeutic drug monitoring (TDM) per standard of care. At the time of TDM, each subject will have a vancomycin concentration obtained at the most informative sampling time to estimate AUC, as determined by the multiple-model optimal sampling function in PMetrics (population PK modeling program). Investigators will then compare the AUC determined using Bayesian estimation and the subject's optimally timed vancomycin concentration to the AUC determined using Bayesian estimation with all available concentrations (TDM samples plus the optimally timed sample). Investigators will also examine how AUC estimation compares to AUC calculated using standard-of-care methods (ie, log-linear equations). Further, Investigators will evaluate how well the population PK model, along with a subject's measured covariates and the optimally timed PK sample, can predict a subject's future vancomycin AUC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Cohort | Recipients of vancomycin |
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| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Vancomycin Area Under the Curve (AUC) From Optimally Timed Concentration | This 24-hour vancomycin area under the curve (AUC) will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and the optimally timed vancomycin concentration | within 24-48 hours following enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Vancomycin Area Under the Curve (AUC) Estimated Using All Available Vancomycin Concentrations | This 24-hour vancomycin area under the curve (AUC) will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and all available measured vancomycin concentrations | within 24-48 hours following enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Participants aged 1-17 years receiving standard of care IV vancomycin for a suspected or confirmed infection will be enrolled at Children's Hospital of Philadelphia.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39846757 | Derived | Downes KJ, Sharova A, Malone J, Odom John AR, Zuppa AF, Neely MN. Multiple Model Optimal Sampling Promotes Accurate Vancomycin Area-Under-the-Curve Estimation Using a Single Sample in Critically Ill Children. Ther Drug Monit. 2025 Jan 23;47(4):512-519. doi: 10.1097/FTD.0000000000001293. |
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Of 29 enrolled participants, 22 met inclusion criteria and had optimal sampling time determination performed.
Participants were recruited based on clinical receipt of IV vancomycin for a suspected infection and plans for therapeutic drug monitoring.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Cohort | Recipients of vancomycin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Of 29 enrolled participants, 22 met inclusion criteria and had optimal sampling time determination performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Cohort | Recipients of vancomycin |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 24-hour Vancomycin Area Under the Curve (AUC) From Optimally Timed Concentration | This 24-hour vancomycin area under the curve (AUC) will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and the optimally timed vancomycin concentration | Posted | Median | Full Range | mg*hr/L | within 24-48 hours following enrollment |
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Adverse Events were not monitored/assessed as this was an observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Cohort | Recipients of vancomycin | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Downes | Children's Hospital of Philadelphia | 215-590-4024 | downeskj@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2023 | Oct 23, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 2, 2023 | Nov 14, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D016638 | Critical Illness |
| D007239 | Infections |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Urine and plasma
| 24-hour Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods | This 24-hour vancomycin area under the curve (AUC) will be calculated using standard clinical methods (Zaske-Sawchuk method) | within 24-48 hours following enrollment |
| Visit 2 Vancomycin Area Under the Curve (AUC) Using Optimally Timed Concentration | The predicted 24-hour vancomycin area under the curve (AUC) at visit 2 will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and the optimally timed vancomycin concentration at visit 1 | 24-72 hours after visit 1 |
| Visit 2 Vancomycin Area Under the Curve (AUC) Using All Available Vancomycin Concentrations | The predicted 24-hour vancomycin area under the curve (AUC) at visit 2 will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and all available vancomycin concentrations | 24-72 hours after visit 1 |
| Visit 2 Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods | This 24-hour vancomycin area under the curve (AUC) will be calculated using standard clinical methods (Zaske-Sawchuk method) based on measured concentrations at visit 2 | 24-72 hours after visit 1 |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Median | Full Range | kilograms |
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| Estimated glomerular filtration rate (GFR) | Median | Full Range | mL/min/1.73m^2 |
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| Secondary | 24-hour Vancomycin Area Under the Curve (AUC) Estimated Using All Available Vancomycin Concentrations | This 24-hour vancomycin area under the curve (AUC) will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and all available measured vancomycin concentrations | Posted | Median | Full Range | mg*hr/L | within 24-48 hours following enrollment |
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| Secondary | 24-hour Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods | This 24-hour vancomycin area under the curve (AUC) will be calculated using standard clinical methods (Zaske-Sawchuk method) | Posted | Median | Full Range | mg*hr/L | within 24-48 hours following enrollment |
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| Secondary | Visit 2 Vancomycin Area Under the Curve (AUC) Using Optimally Timed Concentration | The predicted 24-hour vancomycin area under the curve (AUC) at visit 2 will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and the optimally timed vancomycin concentration at visit 1 | Given the short timeframe, only 11 subjects had data available for this outcome measure. | Posted | Median | Full Range | mg*hr/L | 24-72 hours after visit 1 |
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| Secondary | Visit 2 Vancomycin Area Under the Curve (AUC) Using All Available Vancomycin Concentrations | The predicted 24-hour vancomycin area under the curve (AUC) at visit 2 will be estimated using Bayesian estimation based on the population pharmacokinetic (PK) model, a subject's measured covariates and all available vancomycin concentrations | Given the short timeframe, only 11 subjects had data available for this outcome measure. | Posted | Median | Full Range | mg*hr/L | 24-72 hours after visit 1 |
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| Secondary | Visit 2 Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods | This 24-hour vancomycin area under the curve (AUC) will be calculated using standard clinical methods (Zaske-Sawchuk method) based on measured concentrations at visit 2 | Given the short timeframe, only 7 subjects had data available for this outcome measure. | Posted | Median | Full Range | mg*hr/L | 24-72 hours after visit 1 |
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| D020969 | Disease Attributes |
| D064419 | Chemically-Induced Disorders |