Renal Failure, Bacterial Infections, Critical Illness
Conditions
Brief summary
The study's primary objective is to determine plasma and dialysis fluid concentrations in patients prescribed ceftazidime-avibactam as the standard treatment for their infection and requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the prescribed dose meets pharmacodynamic targets.
Interventions
Patients will be started on 2.5 gm IV every 8 hours
Sponsors
Allergan
Temple University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \> 18 years of age * Patients requiring continuous renal replacement therapy (CRRT) due to acute or chronic renal failure * documented or suspected infection requiring a prescription for ceftazidime-avibactam
Exclusion criteria
* Patients on CRRT \< 24 hours * Patients on ceftazidime-avibactam \< 24 hours * Patients unable to remain on CRRT for 32 hours continuously without clotting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ceftazidime effluent concentrations | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) | mg/L |
| Avibactam effluent concentrations | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) | mg/L |
| Ceftazidime plasma concentrations | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) | mg/L |
| Avibactam plasma concentrations | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) | mg/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance (Cl) | 8-hours | L/hr |
| Maximum plasma concentration (Cmax) | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) | mg/L |
| Sieving Coefficient | 8-hours | SC |
| AUC 0 to 8 hours | 8-hours | mg\*hr/L |
| Number of participants with adverse effects as a measure of safety | Days 1-30 | Measure of safety |
| Minimum plasma concentration (Cmin) | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) | mg/L |
| Half-life (t1/2) | 8-hours | hours |
Countries
United States
Contacts
Primary ContactChristina Rose, Pharm.D.
Backup ContactDaniel Mueller, MD
Outcome results
None listed