Trial Outcomes & Findings for Loading Vancomycin Doses in the Emergency Department (NCT NCT01162733)

NCT ID: NCT01162733

Last Updated: 2014-03-13

Results Overview

The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99 participants
• Primary outcome timeframe: 36 hours
• Results posted on: 2014-03-13

Participant Flow

Participant milestones

Measure	Study Drug 1 Vancomycin 15mg/kg Vancomycin : 15mg/kg	Study Drug 2 Vancomycin 30mg/kg Vancomycin : 30mg/kg
Overall Study STARTED	49	50
Overall Study COMPLETED	22	25
Overall Study NOT COMPLETED	27	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Loading Vancomycin Doses in the Emergency Department

Baseline characteristics by cohort

Measure	Study Drug 1 n=49 Participants Vancomycin 15mg/kg Vancomycin : 15mg/kg	Study Drug 2 n=50 Participants Vancomycin 30mg/kg Vancomycin : 30mg/kg	Total n=99 Participants Total of all reporting groups
Age, Customized Greater than 18 years of age	49 participants n=5 Participants	50 participants n=7 Participants	99 participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	50 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 hours

The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.

Outcome measures

Measure	Study Drug 1 n=49 Participants Vancomycin 15mg/kg Vancomycin : 15mg/kg	Study Drug 2 n=50 Participants Vancomycin 30mg/kg Vancomycin : 30mg/kg
Percentage of Participants First Achieving Therapeutic Levels at 36 Hours	20 percentage of participants	18 percentage of participants

PRIMARY outcome

Timeframe: 12 hours

Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL

Outcome measures

Measure	Study Drug 1 n=49 Participants Vancomycin 15mg/kg Vancomycin : 15mg/kg	Study Drug 2 n=50 Participants Vancomycin 30mg/kg Vancomycin : 30mg/kg
Percentage of Participants First Achieving Therapeutic Levels at 12 Hours	3 percentage of participants	34 percentage of participants

Adverse Events

Study Drug 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Study Drug 2

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Study Drug 1 n=49 participants at risk Vancomycin 15mg/kg Vancomycin : 15mg/kg	Study Drug 2 n=50 participants at risk Vancomycin 30mg/kg Vancomycin : 30mg/kg
Cardiac disorders New onset Atrial fibrillation	0.00% 0/49	2.0% 1/50 • Number of events 1
Renal and urinary disorders Renal failure	0.00% 0/49	2.0% 1/50 • Number of events 1

Other adverse events

Measure	Study Drug 1 n=49 participants at risk Vancomycin 15mg/kg Vancomycin : 15mg/kg	Study Drug 2 n=50 participants at risk Vancomycin 30mg/kg Vancomycin : 30mg/kg
Immune system disorders Allergic Reaction	4.1% 2/49 • Number of events 2	4.0% 2/50 • Number of events 2
Skin and subcutaneous tissue disorders Flushing	2.0% 1/49 • Number of events 1	2.0% 1/50 • Number of events 1

Additional Information

Deb Marco

Christiana Care Health System

Phone: 302 733-4130

Email: dmarco@christianacare.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place