Trial Outcomes & Findings for Beta-lactam Pharmacokinetics in Secondary Care (NCT NCT03033394)
NCT ID: NCT03033394
Last Updated: 2021-08-30
Results Overview
Minimum inhibitory concentration (MIC) is the concentration required to visibly inhibit microbial growth in vitro. The MIC for each drug was defined by non-species related breakpoints provided in EUCAST v11.0. Results are given as a fraction of the dosing interval over which the concentration of the unbound drug is greater than the MIC.
Recruitment status
COMPLETED
Target enrollment
65 participants
Primary outcome timeframe
Two to 10 samples taken during the first 120 hours of antimicrobial therapy
Results posted on
2021-08-30
Participant Flow
Participant milestones
| Measure |
Beta-lactam Antibiotic
Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.
Beta-lactam antibiotic: Routine clinical dosing
|
|---|---|
|
Completed Sampling
STARTED
|
65
|
|
Completed Sampling
COMPLETED
|
65
|
|
Completed Sampling
NOT COMPLETED
|
0
|
|
Completed Pharmacokinetic Analysis
STARTED
|
65
|
|
Completed Pharmacokinetic Analysis
COMPLETED
|
59
|
|
Completed Pharmacokinetic Analysis
NOT COMPLETED
|
6
|
|
Completed Final Analysis
STARTED
|
59
|
|
Completed Final Analysis
COMPLETED
|
58
|
|
Completed Final Analysis
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Beta-lactam Antibiotic
Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.
Beta-lactam antibiotic: Routine clinical dosing
|
|---|---|
|
Completed Pharmacokinetic Analysis
Missing data
|
1
|
|
Completed Pharmacokinetic Analysis
Oral dosing not incorporated into pharmacokinetic model
|
3
|
|
Completed Pharmacokinetic Analysis
Level taken at incorrect time
|
1
|
|
Completed Pharmacokinetic Analysis
Pharmacokinetic soffware unable to generate predicted values
|
1
|
|
Completed Final Analysis
1 participant excluded from final analysis as an outlier (>1.5 x interquartile range)
|
1
|
Baseline Characteristics
6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
Baseline characteristics by cohort
| Measure |
Beta-lactam Antibiotic
n=65 Participants
Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.
Beta-lactam antibiotic: Routine clinical dosing
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Age, Categorical
>=65 years
|
27 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Age, Continuous
|
62 years
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Sex: Female, Male
Female
|
18 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Sex: Female, Male
Male
|
41 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Race (NIH/OMB)
White
|
31 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=59 Participants • 6 patients excluded from pharmacokinetic analysis: * 1 participant missing data * 3 oral dosing could not be integrated into model * 1 level taken incorrect time * 1 model unable to calculate individual predicted value
|
PRIMARY outcome
Timeframe: Two to 10 samples taken during the first 120 hours of antimicrobial therapyMinimum inhibitory concentration (MIC) is the concentration required to visibly inhibit microbial growth in vitro. The MIC for each drug was defined by non-species related breakpoints provided in EUCAST v11.0. Results are given as a fraction of the dosing interval over which the concentration of the unbound drug is greater than the MIC.
Outcome measures
| Measure |
Amoxicillin
n=3 Participants
Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.
Beta-lactam antibiotic: Routine clinical dosing
|
Co-amoxiclav
n=7 Participants
Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.
Beta-lactam antibiotic: Routine clinical dosing
|
Ceftriaxone
n=11 Participants
Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.
Beta-lactam antibiotic: Routine clinical dosing
|
Flucloxacillin
n=14 Participants
Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.
Beta-lactam antibiotic: Routine clinical dosing
|
Meropenem
n=13 Participants
Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.
Beta-lactam antibiotic: Routine clinical dosing
|
Piperacillin-tazobactam
n=10 Participants
Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.
Beta-lactam antibiotic: Routine clinical dosing
|
|---|---|---|---|---|---|---|
|
Fraction of the Dosing Interval Over Which the Concentration of Unbound Drug is Greater Than the Minimum Inhibitory Concentration (fT>MIC)
|
0.457 unitless
Interval 0.417 to 0.479
|
0.429 unitless
Interval 0.417 to 0.479
|
0.747 unitless
Interval 0.741 to 1.04
|
0.417 unitless
Interval 0.285 to 0.7
|
0.333 unitless
Interval 0.319 to 0.345
|
1.63 unitless
Interval 0.971 to 1.78
|
Adverse Events
Beta-lactam Antibiotic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place