Infection During Renal Replacement TherapyPhase 4NCT02007122
Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy
A Phase 4 study testing Ceftaroline in CRRT and Ceftaroline in IRRT in people with Infection During Renal Replacement Therapy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection During Renal Replacement Therapy
- What is being tested?
- Ceftaroline in CRRT and Ceftaroline in IRRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2013to Mar 2023
- Phase
- Phase 4
- 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
Who may be able to join
- Age >18 years, able to give written informed consent
- Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- Renal replacement therapy (continuous or intermittent)
Who cannot join
- Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- An expected survival of less than two days.
- Known pregnancy
- Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
- Ceftaroline as monotherapy for resistent species or fungal infections.
- Other reasons oposing the study participation on the discretion of the investigators
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1190
Florian Thalhammer, Prof. MD, 0043140400, florian.thalhammer@meduniwien.ac.at
Florian Thalhammer, Prof. MD
About this study
The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.
- Being tested
- Ceftaroline in CRRT, Ceftaroline in IRRT
- Keywords
- HD, CVVH, renal replacement therapy, ceftaroline, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftaroline in CRRTOther
Plasma levels of ceftaroline will be measured in patients receiving CRRT
Ceftaroline in IRRTOther
Ceftaroline plasma levels will be measured in patients receiving intermittent renal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| IRRT | Experimental | Ceftaroline levels are measured in patients receiving intermittent renal replacement therapy Receives: Other: Ceftaroline in IRRT |
| CRRT | Experimental | Ceftaroline levels are measured in patients receiving continuous renal replacement therapy Receives: Other: Ceftaroline in CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels.
Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection During Renal Replacement TherapyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Thalhammer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007122
- Sponsor's protocol ID
- CEFTAROLINE_RRT
- Status last verified
- Apr 2022
- First submitted
- 5 Dec 2013
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT02007122
- Acronym / sponsor ID
- CEFTAROLINE_RRT
- Keywords
- HD, CVVH, renal replacement therapy, ceftaroline, pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 10 Dec 2013 (estimated)
- 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 will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRRT | Experimental | Other: Ceftaroline in IRRTCeftaroline levels are measured in patients receiving intermittent renal replacement therapy |
| CRRT | Experimental | Other: Ceftaroline in CRRTCeftaroline levels are measured in patients receiving continuous renal replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years, able to give written informed consent
- Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- Renal replacement therapy (continuous or intermittent)
Key exclusion criteria (6 listed)
- Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- An expected survival of less than two days.
- Known pregnancy
- Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
- Ceftaroline as monotherapy for resistent species or fungal infections.
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 |
|---|---|---|
| Ceftaroline in CRRTPlasma levels of ceftaroline will be measured in patients receiving CRRT | Other | CRRT |
| Ceftaroline in IRRTCeftaroline plasma levels will be measured in patients receiving intermittent renal replacement therapy | Other | IRRT |
Primary outcome
Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels.
Time frame: day 15
Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
Related trials for Infection During Renal Replacement Therapy
Not yet recruiting
The Effect of Standard vs. Shorter Filter Lifespan During Continuous Renal Replacement Therapy
Acute Kidney Injury
RecruitingPhase 1/2
Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate in Sepsis-Associated Acute Kidney Injury
Acute Kidney Injury, Sepsis
RecruitingObservational study
In Vivo Antibiotics Removal During Hemoadsorption Cartridges and Continuous Renal Replacement Therapy in the Intensive Care Unit
Septic Shock
Recruiting
To Compare the Efficacy and Safety of Using oXiris and M100 During CRRT
AKI - Acute Kidney Injury, Pneumonia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftaroline in CRRT and Ceftaroline in IRRT in people with Infection During Renal Replacement Therapy, run by Medical University of Vienna at 1 site in Austria.
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 6 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 14 Apr 2022. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Florian Thalhammer, Prof. MD (0043 1 40400 ext. 4440, florian.thalhammer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels. (time frame: day 15). 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 14 Apr 2022.