Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Drug: Ceftazidime-avibactam
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.
|
Outcome Measures
Primary Outcome Measures
- Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients [8 hours]
PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult patients receiving ceftazidime-avibactam as standard care
Exclusion Criteria:
- Less than 18 years-old
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
- Allergan
Investigators
- Principal Investigator: Ryan Shields, Pharm D, University of Pittsburgh
Study Documents (Full-Text)
More Information
Publications
None provided.- I# 0058410
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Subjects Included |
|---|---|
| Arm/Group Description | 20 patients meeting inclusion criteria were enrolled into the trial |
| Period Title: Overall Study | |
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Subjects Included |
|---|---|
| Arm/Group Description | 20 patients meeting inclusion criteria were enrolled into the trial |
| Overall Participants | 20 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
18
90%
|
| >=65 years |
2
10%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
9
45%
|
| Male |
11
55%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
18
90%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
2
10%
|
Outcome Measures
| Title | Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients |
|---|---|
| Description | PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration |
| Time Frame | 8 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Subjects Included |
|---|---|
| Arm/Group Description | 20 patients meeting inclusion criteria were enrolled into the trial |
| Measure Participants | 20 |
| Ceftazidime Cmax |
80.6
|
| Avibactam Cmax |
15.9
|
Adverse Events
| Time Frame | Adverse events were monitored until the end of ceftazidime-avibactam treatment, up to 14 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Subjects Included | |
| Arm/Group Description | 20 patients meeting inclusion criteria were enrolled into the trial | |
All Cause Mortality |
||
| Subjects Included | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/20 (15%) | |
Serious Adverse Events |
||
| Subjects Included | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Subjects Included | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. Ryan Shields, Associate Professor of Medicine |
|---|---|
| Organization | University of Pittsburgh |
| Phone | 412-864-3745 |
| shieldsrk@upmc.edu |
- I# 0058410