Trial Outcomes & Findings for Use of a Loading Dose of Vancomycin in Pediatric Dosing (NCT NCT01290237)

Results Overview

proportion of participants whose vancomycin trough was between 15 and 20 mcg/mL, 8 hours after the first vancomycin dose, in loading dose group as compared to control group

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

8 hours after the first dose of vancomycin

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Vancomycin Loading Dose Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms	Control Intravenous vancomycin 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms
Overall Study STARTED	30	29
Overall Study COMPLETED	19	27
Overall Study NOT COMPLETED	11	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of a Loading Dose of Vancomycin in Pediatric Dosing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vancomycin Loading Dose n=30 Participants Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms	Control n=29 Participants Intravenous vancomycin 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms	Total n=59 Participants Total of all reporting groups
Age, Continuous	8.63 years STANDARD_DEVIATION 4.4 • n=5 Participants	8.76 years STANDARD_DEVIATION 4.04 • n=7 Participants	8.70 years STANDARD_DEVIATION 4.22 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	29 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours after the first dose of vancomycin

Population: Loading dose - trough at 8 hours was not collected for 11 participants: vancomycin was discontinued prior to second dose (7), participant changed their mind (1), other reason (3) Among participants allocated to conventional treatment, trough at 8 hours was not collected for 2: vancomycin discontinued prior to second dose (1), changed mind (1)

proportion of participants whose vancomycin trough was between 15 and 20 mcg/mL, 8 hours after the first vancomycin dose, in loading dose group as compared to control group

Outcome measures

Outcome measures
Measure	Vancomycin Loading Dose n=19 Participants Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms	Control n=27 Participants Intravenous vancomycin 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms
Count of Participants With Vancomycin Trough Between 15 and 20	2 Participants	0 Participants

SECONDARY outcome

Timeframe: within 48 hours after receiving the first dose of vancomycin

Population: Number of measurements reflects the number of participants with blood samples available for testing

AUC/MIC using hypothetical MIC = 1 mg/L

Outcome measures

Outcome measures
Measure	Vancomycin Loading Dose n=25 Participants Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms	Control n=26 Participants Intravenous vancomycin 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms
AUC/MIC for Vancomycin in the Study Population	446.5 AUC/MIC ratio Standard Deviation 195.5	434.0 AUC/MIC ratio Standard Deviation 153.2

Adverse Events

Vancomycin Loading Dose

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vancomycin Loading Dose n=30 participants at risk Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms	Control n=29 participants at risk Intravenous vancomycin 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms
Renal and urinary disorders acute kidney injury	3.3% 1/30 • Number of events 1	0.00% 0/29

Other adverse events

Other adverse events
Measure	Vancomycin Loading Dose n=30 participants at risk Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms	Control n=29 participants at risk Intravenous vancomycin 20 mg/kg/dose every 8 hours intravenous vancomycin hydrochloride: see description of study arms
Skin and subcutaneous tissue disorders Red man syndrome	46.7% 14/30 • Number of events 14	24.1% 7/29 • Number of events 7
General disorders Escalation of care within 7 days	6.7% 2/30 • Number of events 2	10.3% 3/29 • Number of events 3
Renal and urinary disorders Doubling of baseline creatinine	13.3% 4/30 • Number of events 4	3.4% 1/29 • Number of events 1

Additional Information

Dr. Alicia Demirjian

Boston Children's Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place