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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftazidime and Avibactam | Ceftazidime-avibactam pharmacokinetic monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftazidime-avibactam | Drug | Patients will be started on 2.5 gm IV every 8 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ceftazidime plasma concentrations | mg/L | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) |
| Avibactam plasma concentrations | mg/L | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) |
| Ceftazidime effluent concentrations | mg/L | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) |
| Avibactam effluent concentrations | mg/L | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | mg/L | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) |
| Number of participants with adverse effects as a measure of safety |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Rose, Pharm.D. | Contact | 215-707-8057 | rosecm@temple.edu | |
| Daniel Mueller, MD | Contact | 215-707-1982 | Daniel.Mueller2@tuhs.temple.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christina Rose, Pharm.D. | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
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Whole blood, plasma, effluent fluid from dialysis machine
Measure of safety
| Days 1-30 |
| Minimum plasma concentration (Cmin) | mg/L | At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose) |
| Half-life (t1/2) | hours | 8-hours |
| Clearance (Cl) | L/hr | 8-hours |
| AUC 0 to 8 hours | mg*hr/L | 8-hours |
| Sieving Coefficient | SC | 8-hours |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D001424 | Bacterial Infections |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000595613 | avibactam, ceftazidime drug combination |
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