Trial Outcomes & Findings for Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance (NCT NCT04147221)
NCT ID: NCT04147221
Last Updated: 2024-08-06
Results Overview
The clearance in liters/hour of imipenem from the plasma of critically ill patients with augmented renal clearance
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
6 hours [Timepoints taken at 0 hour (within 30 minutes prior to the start of infusion), 0.5 hours (end of infusion), 0.75, 1, 2, 4, and 6 hours after the start of the infusion]
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
Imipenem-Relebactam
Participants will receive a single dose of intravenous imipenem-relebactam (500mg-250mg) as a 30 minute infusion.
Imipenem-relebactam: After receipt of imipenem-relebactam, participants will have six blood samples collected over 6 hours for determination of imipenem and relebactam concentrations.
|
|---|---|
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Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance
Baseline characteristics by cohort
| Measure |
Imipenem-Relebactam
n=8 Participants
Participants will receive a single dose of intravenous imipenem-relebactam (500mg-250mg) as a 30 minute infusion.
Imipenem-relebactam: After receipt of imipenem-relebactam, participants will have six blood samples collected over 6 hours for determination of imipenem and relebactam concentrations.
|
|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 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
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
|
Total Body Weight
|
89 kg
STANDARD_DEVIATION 16 • n=5 Participants
|
|
APACHE II Score
|
16 scores on a scale
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Cockcroft-Gault CrCL
|
193 mL/min
STANDARD_DEVIATION 62 • n=5 Participants
|
|
Urine Measured CrCL
|
156 mL/min
STANDARD_DEVIATION 37 • n=5 Participants
|
|
Albumin
|
2.8 mg/dL
STANDARD_DEVIATION 0.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hours [Timepoints taken at 0 hour (within 30 minutes prior to the start of infusion), 0.5 hours (end of infusion), 0.75, 1, 2, 4, and 6 hours after the start of the infusion]The clearance in liters/hour of imipenem from the plasma of critically ill patients with augmented renal clearance
Outcome measures
| Measure |
Imipenem-Relebactam
n=8 Participants
Participants will receive a single dose of intravenous imipenem-relebactam (500mg-250mg) as a 30 minute infusion.
Imipenem-relebactam: After receipt of imipenem-relebactam, participants will have six blood samples collected over 6 hours for determination of imipenem and relebactam concentrations.
|
|---|---|
|
Imipenem Clearance
|
17.31 L/h
Standard Deviation 5.67
|
PRIMARY outcome
Timeframe: 6 hours [Timepoints taken at 0 hour (within 30 minutes prior to the start of infusion), 0.5 hours (end of infusion), 0.75, 1, 2, 4, and 6 hours after the start of the infusion]The clearance in liters/hour of relebactam from the plasma of critically ill patients with augmented renal clearance
Outcome measures
| Measure |
Imipenem-Relebactam
n=8 Participants
Participants will receive a single dose of intravenous imipenem-relebactam (500mg-250mg) as a 30 minute infusion.
Imipenem-relebactam: After receipt of imipenem-relebactam, participants will have six blood samples collected over 6 hours for determination of imipenem and relebactam concentrations.
|
|---|---|
|
Relebactam Clearance
|
11.51 L/h
Standard Deviation 4.79
|
SECONDARY outcome
Timeframe: 6 hours [Timepoints taken at 0 hour (within 30 minutes prior to the start of infusion), 0.5 hours (end of infusion), 0.75, 1, 2, 4, and 6 hours after the start of the infusion]The AUC in milligram\*hour/liter of imipenem calculated from concentrations collected between zero-6 hours and then extrapolated to infinity
Outcome measures
| Measure |
Imipenem-Relebactam
n=8 Participants
Participants will receive a single dose of intravenous imipenem-relebactam (500mg-250mg) as a 30 minute infusion.
Imipenem-relebactam: After receipt of imipenem-relebactam, participants will have six blood samples collected over 6 hours for determination of imipenem and relebactam concentrations.
|
|---|---|
|
Imipenem Area Under the Curve (AUC)
|
32.33 mg*h/L
Standard Deviation 11.60
|
SECONDARY outcome
Timeframe: 6 hours [Timepoints taken at 0 hour (within 30 minutes prior to the start of infusion), 0.5 hours (end of infusion), 0.75, 1, 2, 4, and 6 hours after the start of the infusion]The AUC in milligram\*hour/liter of relebactam calculated from concentrations collected between zero-6 hours and then extrapolated to infinity
Outcome measures
| Measure |
Imipenem-Relebactam
n=8 Participants
Participants will receive a single dose of intravenous imipenem-relebactam (500mg-250mg) as a 30 minute infusion.
Imipenem-relebactam: After receipt of imipenem-relebactam, participants will have six blood samples collected over 6 hours for determination of imipenem and relebactam concentrations.
|
|---|---|
|
Relebactam Area Under the Curve (AUC)
|
25.54 mg*h/L
Standard Deviation 10.21
|
Adverse Events
Imipenem-Relebactam
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 |
Imipenem-Relebactam
n=9 participants at risk
Participants will receive a single dose of intravenous imipenem-relebactam (500mg-250mg) as a 30 minute infusion.
Imipenem-relebactam: After receipt of imipenem-relebactam, participants will have six blood samples collected over 6 hours for determination of imipenem and relebactam concentrations.
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|---|---|
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Cardiac disorders
Bradycardia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected over a 24 hour window, from the first (and only) imipenem-relebactam dose (0 hour) to the end of blood sampling (6 hours), plus an 18 hour observation window after the last sample was collected, culminating with physical exam. Note: 9 subjects were enrolled and received imipenem-relebactam. Although only 8 subjects were included in results analysis due to inability to obtain blood samples in 1 subject, all 9 subjects are included in the adverse event reporting.
Adverse event - any pathologic or unintended change in the structure (signs), function (symptoms), or chemistry (laboratory values) of the body associated with the use of the study drug, whether or not considered drug related: MILD - present, but easily tolerated MODERATE - discomfort that interferes with usual activities SEVERE - incapacitating, inability to work or do usual activities
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Additional Information
Dr. Joseph L. Kuti
Center for Anti Infective Research and Development
Phone: 860-972-3612
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place