Renal FailureNCT03243864
Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis
An observational study of Renal Failure and Bacterial Infections, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Bacterial Infections, Critical Illness
- What is being tested?
- Ceftazidime-avibactam
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2017to 21 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients
Who may be able to join
- 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
Who cannot join
- Patients on CRRT < 24 hours
- Patients on ceftazidime-avibactam < 24 hours
- Patients unable to remain on CRRT for 32 hours continuously without clotting
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Christina Rose, Pharm.D., 215-707-8057, rosecm@temple.edu
About this study
Official title: : Pharmacokinetics of Ceftazidime-Avibactam in Critically Ill Patients With Renal Failure Requiring Continuous Venovenous Hemodiafiltration
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.
- Conditions
- Renal Failure, Bacterial Infections, Critical Illness
- Being tested
- Ceftazidime-avibactam
- Medical subject headings
- Renal Insufficiency, Bacterial Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftazidime-avibactamDrug
Also called Avycaz
Patients will be started on 2.5 gm IV every 8 hours
| Study group | Role | What they receive |
|---|---|---|
| Ceftazidime and Avibactam | Ceftazidime-avibactam pharmacokinetic monitoring Receives: Drug: Ceftazidime-avibactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ceftazidime plasma concentrations
mg/L
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (7)
Maximum plasma concentration (Cmax)
mg/L
Measured: 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
Measure of safety
Measured: Days 1-30
Minimum plasma concentration (Cmin)
mg/L
Measured: 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
Measured: 8-hours
Clearance (Cl)
L/hr
Measured: 8-hours
AUC 0 to 8 hours
mg*hr/L
Measured: 8-hours
Sieving Coefficient
SC
Measured: 8-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start13 Mar 2017
- Primary completion21 Mar 2020 (estimated)
- Study completion21 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Christina Rose, Pharm.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243864
- Sponsor's protocol ID
- 866
- Status last verified
- Apr 2019
- First submitted
- 1 Aug 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : Pharmacokinetics of Ceftazidime-Avibactam in Critically Ill Patients With Renal Failure Requiring Continuous Venovenous Hemodiafiltration
- ClinicalTrials.gov ID
- NCT03243864
- Acronym / sponsor ID
- 866
- Conditions
- Renal Failure, Bacterial Infections, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 21 Mar 2020 (estimated)
- Study completion
- 21 Oct 2020 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftazidime and Avibactam | – | Drug: Ceftazidime-avibactamCeftazidime-avibactam pharmacokinetic monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients on CRRT < 24 hours
- Patients on ceftazidime-avibactam < 24 hours
- Patients unable to remain on CRRT for 32 hours continuously without clotting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftazidime-avibactamAlso: AvycazPatients will be started on 2.5 gm IV every 8 hours | Drug | Ceftazidime and Avibactam |
Primary outcome
Ceftazidime plasma concentrations
Time frame: 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
Time frame: 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 effluent concentrations
Time frame: 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
Time frame: 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
7 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 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
Time frame: Days 1-30
Minimum plasma concentration (Cmin)
Time frame: 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)
Time frame: 8-hours
Clearance (Cl)
Time frame: 8-hours
AUC 0 to 8 hours
Time frame: 8-hours
Sieving Coefficient
Time frame: 8-hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Rose, Pharm.D. principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure and Bacterial Infections, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Rose, Pharm.D. (215-707-8057, rosecm@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ceftazidime plasma concentrations (time frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.