Trial Outcomes & Findings for Optimizing Vancomycin Therapy in Children (NCT NCT05691309)

Last Updated: 2024-12-20

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

29 participants

Primary outcome timeframe

within 24-48 hours following enrollment

Results posted on

2024-12-20

Participant Flow

Participants were recruited based on clinical receipt of IV vancomycin for a suspected infection and plans for therapeutic drug monitoring.

Of 29 enrolled participants, 22 met inclusion criteria and had optimal sampling time determination performed.

Participant milestones

Participant milestones
Measure	Study Cohort Recipients of vancomycin
Overall Study STARTED	22
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Cohort Recipients of vancomycin
Overall Study vancomycin discontinued by clinical team	2
Overall Study vancomycin levels not evaluable	2

Baseline Characteristics

Optimizing Vancomycin Therapy in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Cohort n=18 Participants Recipients of vancomycin
Age, Categorical <=18 years	18 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	6.1 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Weight	20 kilograms n=5 Participants
Estimated glomerular filtration rate (GFR)	136 mL/min/1.73m^2 n=5 Participants

PRIMARY outcome

Timeframe: within 24-48 hours following enrollment

Outcome measures

Outcome measures
Measure	Study Cohort n=18 Participants Recipients of vancomycin
24-hour Vancomycin Area Under the Curve (AUC) From Optimally Timed Concentration	494 mg*hr/L Interval 347.0 to 1008.0

SECONDARY outcome

Timeframe: within 24-48 hours following enrollment

Outcome measures

Outcome measures
Measure	Study Cohort n=18 Participants Recipients of vancomycin
24-hour Vancomycin Area Under the Curve (AUC) Estimated Using All Available Vancomycin Concentrations	495 mg*hr/L Interval 336.0 to 1084.0

SECONDARY outcome

Timeframe: within 24-48 hours following enrollment

This 24-hour vancomycin area under the curve (AUC) will be calculated using standard clinical methods (Zaske-Sawchuk method)

Outcome measures

Outcome measures
Measure	Study Cohort n=18 Participants Recipients of vancomycin
24-hour Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods	526 mg*hr/L Interval 258.0 to 1111.0

SECONDARY outcome

Timeframe: 24-72 hours after visit 1

Population: Given the short timeframe, only 11 subjects had data available for this outcome measure.

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

Outcome measures

Outcome measures
Measure	Study Cohort n=11 Participants Recipients of vancomycin
Visit 2 Vancomycin Area Under the Curve (AUC) Using Optimally Timed Concentration	500 mg*hr/L Interval 326.0 to 668.0

SECONDARY outcome

Timeframe: 24-72 hours after visit 1

Population: Given the short timeframe, only 11 subjects had data available for this outcome measure.

Outcome measures

Outcome measures
Measure	Study Cohort n=11 Participants Recipients of vancomycin
Visit 2 Vancomycin Area Under the Curve (AUC) Using All Available Vancomycin Concentrations	502 mg*hr/L Interval 370.0 to 681.0

SECONDARY outcome

Timeframe: 24-72 hours after visit 1

Population: Given the short timeframe, only 7 subjects had data available for this outcome measure.

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

Outcome measures

Outcome measures
Measure	Study Cohort n=7 Participants Recipients of vancomycin
Visit 2 Vancomycin Area Under the Curve (AUC) Calculated Using Standard-of-care Methods	486 mg*hr/L Interval 305.0 to 754.0

Adverse Events

Study Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kevin Downes

Children's Hospital of Philadelphia

Phone: 215-590-4024

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place