Trial Outcomes & Findings for Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin (NCT NCT04648696)
NCT ID: NCT04648696
Last Updated: 2024-02-14
Results Overview
Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
8 participants
Primary outcome timeframe
week 8
Results posted on
2024-02-14
Participant Flow
1 Subject Screen Failed who never received study treatment
Participant milestones
| Measure |
Continuous Infusions (CI) Group
continuous infusions (CI) group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
|
Intermittent Infusion (II) Group
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin
Baseline characteristics by cohort
| Measure |
Continuous Infusions (CI) Group
n=4 Participants
CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
|
Intermittent Infusion (II) Group
n=3 Participants
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
57 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 8Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements
Outcome measures
| Measure |
Continuous Infusions (CI) Group
n=4 Participants
CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
|
Intermittent Infusion (II) Group
n=3 Participants
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
|---|---|---|
|
Number of Nephrotoxicity in Subjects
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: week 8Number of Subjects with White Blood Cell (WBC) \< 4,000 x 103 cells/µL
Outcome measures
| Measure |
Continuous Infusions (CI) Group
n=4 Participants
CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
|
Intermittent Infusion (II) Group
n=3 Participants
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
|---|---|---|
|
Number of Leukopenia in Subjects
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 8Flushing/Erythema /Rash/Red Man Syndrome
Outcome measures
| Measure |
Continuous Infusions (CI) Group
n=4 Participants
CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
|
Intermittent Infusion (II) Group
n=3 Participants
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
|---|---|---|
|
Number of Infusion-related Reactions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 8Number of Serum Vancomycin Measurements Within Therapeutic Range If inpatient dose was determined by AUC monitoring: A vancomycin trough that is within 3.0 mcg/mL of the trough that correlated with a therapeutic AUC based on inpatient monitoring - If inpatient dose was not determined by AUC monitoring or vancomycin was initiated as outpatient: A vancomycin trough of 10.0 - 20.0 mcg/mL
Outcome measures
| Measure |
Continuous Infusions (CI) Group
n=15 Number of blood draws
CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
|
Intermittent Infusion (II) Group
n=8 Number of blood draws
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
|---|---|---|
|
Number of Serum Vancomycin Measurements Within Therapeutic Range
|
9 Number of Blood Draws
|
2 Number of Blood Draws
|
SECONDARY outcome
Timeframe: week 8Number of Subjects without need for additional induction therapy beyond the planned end date
Outcome measures
| Measure |
Continuous Infusions (CI) Group
n=4 Participants
CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
|
Intermittent Infusion (II) Group
n=3 Participants
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
|---|---|---|
|
Number of Participants With Resolutions of Symptoms Associated With the Infection
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: week 21Number of Participants with Persistence, new onset, or worsening local or systemic signs and symptoms of infection
Outcome measures
| Measure |
Continuous Infusions (CI) Group
n=4 Participants
CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
|
Intermittent Infusion (II) Group
n=3 Participants
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
|---|---|---|
|
Number of Participants With Treatment Failures
|
2 Participants
|
2 Participants
|
Adverse Events
Continuous Infusions (CI) Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intermittent Infusion (II) Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuous Infusions (CI) Group
n=4 participants at risk
CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
|
Intermittent Infusion (II) Group
n=3 participants at risk
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4 • Number of events 1 • up to 21 weeks
|
0.00%
0/3 • up to 21 weeks
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
25.0%
1/4 • Number of events 1 • up to 21 weeks
|
0.00%
0/3 • up to 21 weeks
|
|
Renal and urinary disorders
nephrotoxicity
|
0.00%
0/4 • up to 21 weeks
|
33.3%
1/3 • Number of events 1 • up to 21 weeks
|
Additional Information
John Williamson, PhD
Wake Forest University Health Sciences
Phone: 336.713.3431
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place