Clinical trial NCT03243864: Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis
Official title: : Pharmacokinetics of Ceftazidime-Avibactam in Critically Ill Patients With Renal Failure Requiring Continuous Venovenous Hemodiafiltration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Failure
Bacterial Infections
Critical Illness
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2017-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ceftazidime plasma concentrations
timeFrame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
measure: Avibactam plasma concentrations
timeFrame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
measure: Ceftazidime effluent concentrations
timeFrame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
measure: Avibactam effluent concentrations
timeFrame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
measure: Number of participants with adverse effects as a measure of safety
timeFrame: Days 1-30
measure: Minimum plasma concentration (Cmin)
timeFrame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
measure: Half-life (t1/2)
timeFrame: 8-hours
measure: Clearance (Cl)
timeFrame: 8-hours
measure: AUC 0 to 8 hours
timeFrame: 8-hours
measure: Sieving Coefficient
timeFrame: 8-hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Christina Rose, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: