SepsisPhase 4NCT02365272
Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department
A Phase 4 study testing Amikacin in people with Sepsis, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Amikacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2014
- 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
- patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied
Who cannot join
- < 18 years
- pregnancy
- burns
- amikacin treatment in the previous 2 weeks
- known allergy to aminoglycosides
- Do Not Reanimate Code ≥ 2
- Hospitalized patients with a prolonged deep venous or arterial catheder
- Continuous renal replacement, intermittent hemodialysis and death within the time of start of amikacin replacement and 1 hour later
About this study
Official title: Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Amikacin in Patients With Severe Sepsis or Septic Shock Admitted at the Emergency Department(ED)
The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock.
- Conditions
- Sepsis
- Being tested
- Amikacin
- Keywords
- pharmacokinetics, aminoglycosides
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmikacinDrug
Amikacin administered in a single dose for critical care patients
| Study group | Role | What they receive |
|---|---|---|
| amikacin standard dose | Active comparator | amikacin in a single standard dose Receives: Drug: Amikacin |
| amikacin dose for critical care patients | Active comparator | amikacin in a single dose for critical care patients Receives: Drug: Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with amikacin PK/PD target attainment
The primary outcome of this study was evaluation of PK/PD target attainment defined as amikacin peak concentration/Minimal Inhibitory Concentration > 8 in the 15 vs.25 mg/kg amikacin group in function of 1) actual MIC of isolated pathogens 2) breakpoints of European Committe on Antimicrobial susceptibility testing (EUCAST) of Enterobacteriaceae and Pseudomonas aeruginosa
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mevr Sabrina De Winter, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Sabrina De Winter, PharmD, Principal investigator, KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365272
- Sponsor's protocol ID
- University Hospitals Leuven
- Status last verified
- Feb 2015
- First submitted
- 27 Jan 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
Publications
Dia N, De Winter S, Gijsen M, Desmet S, Vanbrabant P, Peetermans W, Spriet I, Dreesen E. Dose Optimization of Amikacin in the Emergency Department: A Population Pharmacokinetics Simulation Study. Ther Drug Monit. 2025 Jun 1;47(3):353-362. doi: 10.1097/FTD.0000000000001279. Epub 2024 Dec 3.
PubMed 40344018De Winter S, van Hest R, Dreesen E, Annaert P, Wauters J, Meersseman W, Van den Eede N, Desmet S, Verelst S, Vanbrabant P, Peetermans W, Spriet I. Quantification and Explanation of the Variability of First-Dose Amikacin Concentrations in Critically Ill Patients Admitted to the Emergency Department: A Population Pharmacokinetic Analysis. Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):653-663. doi: 10.1007/s13318-021-00698-w. Epub 2021 Jul 23.
PubMed 34297338De Winter S, Wauters J, Meersseman W, Verhaegen J, Van Wijngaerden E, Peetermans W, Annaert P, Verelst S, Spriet I. Higher versus standard amikacin single dose in emergency department patients with severe sepsis and septic shock: a randomised controlled trial. Int J Antimicrob Agents. 2018 Apr;51(4):562-570. doi: 10.1016/j.ijantimicag.2017.11.009. Epub 2017 Nov 24.
PubMed 29180278
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Amikacin in Patients With Severe Sepsis or Septic Shock Admitted at the Emergency Department(ED)
- ClinicalTrials.gov ID
- NCT02365272
- Acronym / sponsor ID
- University Hospitals Leuven
- Conditions
- Sepsis
- Keywords
- pharmacokinetics, aminoglycosides
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Feb 2015 (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 aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amikacin standard dose | Active comparator | Drug: Amikacinamikacin in a single standard dose |
| amikacin dose for critical care patients | Active comparator | Drug: Amikacinamikacin in a single dose for critical care patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied
Key exclusion criteria (8 listed)
- < 18 years
- pregnancy
- burns
- amikacin treatment in the previous 2 weeks
- known allergy to aminoglycosides
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 |
|---|---|---|
| AmikacinAmikacin administered in a single dose for critical care patients | Drug | amikacin dose for critical care patients, amikacin standard dose |
Primary outcome
Number of participants with amikacin PK/PD target attainment
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
The primary outcome of this study was evaluation of PK/PD target attainment defined as amikacin peak concentration/Minimal Inhibitory Concentration > 8 in the 15 vs.25 mg/kg amikacin group in function of 1) actual MIC of isolated pathogens 2) breakpoints of European Committe on Antimicrobial susceptibility testing (EUCAST) of Enterobacteriaceae and Pseudomonas aeruginosa
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Derived from this study: PubMed 40344018Dia N, De Winter S, Gijsen M, Desmet S, Vanbrabant P, Peetermans W, Spriet I, Dreesen E. Dose Optimization of Amikacin in the Emergency Department: A Population Pharmacokinetics Simulation Study. Ther Drug Monit. 2025 Jun 1;47(3):353-362. doi: 10.1097/FTD.0000000000001279. Epub 2024 Dec 3.
- Derived from this study: PubMed 34297338De Winter S, van Hest R, Dreesen E, Annaert P, Wauters J, Meersseman W, Van den Eede N, Desmet S, Verelst S, Vanbrabant P, Peetermans W, Spriet I. Quantification and Explanation of the Variability of First-Dose Amikacin Concentrations in Critically Ill Patients Admitted to the Emergency Department: A Population Pharmacokinetic Analysis. Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):653-663. doi: 10.1007/s13318-021-00698-w. Epub 2021 Jul 23.
- Derived from this study: PubMed 29180278De Winter S, Wauters J, Meersseman W, Verhaegen J, Van Wijngaerden E, Peetermans W, Annaert P, Verelst S, Spriet I. Higher versus standard amikacin single dose in emergency department patients with severe sepsis and septic shock: a randomised controlled trial. Int J Antimicrob Agents. 2018 Apr;51(4):562-570. doi: 10.1016/j.ijantimicag.2017.11.009. Epub 2017 Nov 24.
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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.
Sabrina De Winter, PharmD principal investigator
KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amikacin in people with Sepsis, run by Universitaire Ziekenhuizen KU Leuven.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with amikacin PK/PD target attainment (time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02365272, which also lists 3 linked publications.
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 18 Feb 2015.