Trial Outcomes & Findings for An Observational Pharmacokinetic Sudy of Ceftolozane-Tazobactam in Intensive Care Unit in Patients With and Without CRRT (NCT NCT02962934)
NCT ID: NCT02962934
Last Updated: 2019-10-02
Results Overview
The probability of attaining free concentrations above MIC for 40% of the time
Recruitment status
COMPLETED
Target enrollment
18 participants
Primary outcome timeframe
24 hour period
Results posted on
2019-10-02
Participant Flow
Participant milestones
| Measure |
Non CRRT Group
Critically ill patients receiving Ceftolozane-Tazobactam not receiving continuous renal replacement therapy
Non CRRT group: Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h.
|
CRRT Group
Critically ill patients receiving Ceftolozane-Tazobactam who require continuous renal replacement therapy
CRRT group: CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h.
Ultrafiltrate samples at 1 hr,2h 4h 6h 8h
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non CRRT Group
n=12 Participants
Critically ill patients receiving Ceftolozane-Tazobactam not receiving continuous renal replacement therapy
Non CRRT group: Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h.
|
CRRT Group
n=6 Participants
Critically ill patients receiving Ceftolozane-Tazobactam who require continuous renal replacement therapy
CRRT group: CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h.
Ultrafiltrate samples at 1 hr,2h 4h 6h 8h
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=12 Participants
|
61.5 years
n=6 Participants
|
58 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=12 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Serum Creatinine
|
46 micro-mole/litre
n=12 Participants
|
138 micro-mole/litre
n=6 Participants
|
75 micro-mole/litre
n=18 Participants
|
PRIMARY outcome
Timeframe: 24 hour periodPopulation: For a recommended dose of 1.5g every 8 hours for patients without CRRT and for a dosing regimen of 3g loading dose plus 0.75 g every 8 hours for patients with CRRT when evaluated at the EUCAST MIC breakpoint of 4mg/L for Pseudomonas aeruginosa
The probability of attaining free concentrations above MIC for 40% of the time
Outcome measures
| Measure |
Non CRRT Group
n=12 Participants
Critically ill patients receiving Ceftolozane-Tazobactam not receiving continuous renal replacement therapy
Non CRRT group: Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h.
|
CRRT Group
n=6 Participants
Critically ill patients receiving Ceftolozane-Tazobactam who require continuous renal replacement therapy
CRRT group: CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h.
Ultrafiltrate samples at 1 hr,2h 4h 6h 8h
|
|---|---|---|
|
Probability of Target Attainment for 40% fT>MIC
|
100 percentage of time above MIC
|
100 percentage of time above MIC
|
Adverse Events
Non CRRT Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CRRT Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Jason Roberts
University of Queensland Center for Clinical Research
Phone: +61 7 334 65032
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place