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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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Ceftazidime-avibactam is used for treatment of invasive Gram-negative bacterial infections among critically ill patients, including those on continuous venovenous hemodiafiltration . However, dosing of ceftazidime-avibactam for these patients remains undefined. The purpose of this study was to evaluate the pharmacokinetics of ceftazidime and avibactam among critically-ill patients, including those receiving CVVHD. This is a registration of Dr. Shields' exempt project under IRB approved research study STUDY19040363
Patients who received ceftazidime-avibactam as part of their clinical care were consented. EMR data was collected as well as PK sampling around their dosing to include the following samples immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, and 8 hours. Blood samples were collected in lithium-heparin tubes from a central venous catheter that is not being used for the continuous venovenous hemodiafiltration. The tubes were centrifuged at 2500 rpm for 10 minutes within 1 hour from collection and the samples will be frozen at 80°C. The total concentrations of ceftazidime and avibactam were determined simultaneously from plasma by using a validated HPLC-tandem MS assay. Noncompartmental pharmacokinetics were calculated using the linear-up and logarithmic-down trapezoidal method, based on the assumption of first-order elimination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| invasive bacterial infections | patients who are receiving Ceftazidime-avibactam are asked to provide blood samples around a dosing of the medication for analysis of samples |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftazidime-avibactam | Drug | collection of blood samples around clinical dosing immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, 8, and 12 hours and EMR review. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients | PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with confirmed or presumed invasive bacterial infections
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Shields, Pharm D | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
De-identified data will be shared through peer-reviewed publication
Within 1 year of study completion
will be on clinicaltrials.gov
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Included | 20 patients meeting inclusion criteria were enrolled into the trial |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Included | 20 patients meeting inclusion criteria were enrolled into the trial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients | PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration | Posted | Median | Inter-Quartile Range | mcg/mL | 8 hours |
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Adverse events were monitored until the end of ceftazidime-avibactam treatment, up to 14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Included | 20 patients meeting inclusion criteria were enrolled into the trial |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Shields, Associate Professor of Medicine | University of Pittsburgh | 412-864-3745 | shieldsrk@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2020 | Apr 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000595613 | avibactam, ceftazidime drug combination |
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Samples will be collected immediately before, and then at the following times thereafter intravenous administration of ceftazidime-avibactam: 1, 2, 4, 6, and 8 hours
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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|
| 3 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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