A Phase 1 interventional study of Ceftazidime/avibactam in Pharmacokinetics of Avycaz in ICU Patients, sponsored by Michigan State University. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-03-06.
Sponsored by Michigan State University · Phase 1, Interventional, and Basic science
The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the Intensive Care Unit (12). This study will include medical and post-surgical patients who develop an infection where Avycaz can be utilized. Since these patients will have variable PK parameters, the investigators will also analyze (time-kill) these serum concentrations (ex vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to determine microbiologic activity of Avycaz in critically ill patients with variable characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 10 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \[other antibiotics can also be administered as needed\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.
Drug: Ceftazidime/avibactam
Ceftazadime/avibactam dosing in ICU patients
Also known as: Avycaz
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients
Time frame: 2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients
Time frame: 2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients
Time frame: 2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients
Time frame: 2,4,6, 8 hours after receiving the drug
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients
Time frame: 2,4,6, 8 hours after receiving the drug
| Milestone | Ceftazadime/Avibactam |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
| Liter | Ceftazadime/Avibactam |
|---|---|
| Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients | 34 ± 12 |
| Hours | Ceftazadime/Avibactam |
|---|---|
| Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients | 4.3 ± 1.9 |
| Liters/hour | Ceftazadime/Avibactam |
|---|---|
| Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients | 6.4 ± 3.4 |
| mg*hour/liters | Ceftazadime/Avibactam |
|---|---|
| Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients | 343 ± 47 |
| mg/liter | Ceftazadime/Avibactam |
|---|---|
| Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients | 48 ± 17 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ceftazadime/Avibactam | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Ceftazadime/Avibactam |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 3 |
| Age, Continuous(years) | Ceftazadime/Avibactam |
|---|---|
| Mean | 55 (37 to 86) |
| Sex: Female, Male(Participants) | Ceftazadime/Avibactam |
|---|---|
| Female | 4 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | Ceftazadime/Avibactam |
|---|
| Region of Enrollment(Participants) | Ceftazadime/Avibactam |
|---|---|
| United States | 10 |
No study locations are listed for this record.
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Plan to share: No
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Michigan State University