SepsisNCT06261164
Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients
An observational study of Sepsis, run by University Clinical Centre of Republic of Srpska at 1 site in Bosnia and Herzegovina.
Trial summary
The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- What is being tested?
- Cytosorb® and Oxiris® adsorbents
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 31 Jan 2024to 31 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult critically ill patients with a diagnosis of SIRS, sepsis and/or septic shock who are hospitalized in the Department of Medical Intensive Care Medicine
Who may be able to join
- diagnosis of SIRS, sepsis and/or septic shock,
- older than 18 years, who are being treated with amikacin and/or vancomycin,
- length of use of adsorbent at least 12 hours.
Who cannot join
- contraindication for hemodiafiltration with adsorbents,
- patients under the age of 18,
- terminal cancer patients.
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
Department of Medical Intensive Care Medicine
Banja Luka, 78000
Nikolina Spiric, MPharm, +38751342295, nikolina.spiric@kc-bl.com
Pedja Kovacevic, Prof.
About this study
Official title: Development and Use of a Population Pharmacokinetic Model of Amikacin and Vancomycin for the Optimization of Dosing Regimens in Critically Ill Patients on Different Modalities of Extracorporeal Hemoadsorption
The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents.
- Conditions
- Sepsis
- Being tested
- Cytosorb® and Oxiris® adsorbents
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytosorb® and Oxiris® adsorbentsDevice
Also called Drugs' concentrations measurements
The pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents.
| Study group | Role | What they receive |
|---|---|---|
| Patients on hemodiafiltration with Cytosorb® | Not described Receives: Device: Cytosorb® and Oxiris® adsorbents | |
| Patients on hemodiafiltration with Oxiris® | Not described Receives: Device: Cytosorb® and Oxiris® adsorbents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of population pharmacokinetic model
Measurement of amikacin and vancomycine serum concentrations in several time points in order to gain pharmacokinetic profiles of previously mentioned drugs and to develop population pharmacokinetic model of amikacin and vancomycin by nonlinear modeling of combined effects in critically ill patients on veno-venous hemodiafiltration with two types of adsorbents.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start31 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Centre of Republic of Srpska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolina Spiric, University Clinical Centre of Republic of Srpska
- Investigators
- Nikolina Spiric, MPharm, Principal investigator, University Clinical Centre of Republic of Srpska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261164
- Sponsor's protocol ID
- 01-19-373- 2/23
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Use of a Population Pharmacokinetic Model of Amikacin and Vancomycin for the Optimization of Dosing Regimens in Critically Ill Patients on Different Modalities of Extracorporeal Hemoadsorption
- ClinicalTrials.gov ID
- NCT06261164
- Acronym / sponsor ID
- 01-19-373- 2/23
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Clinical Centre of Republic of SrpskaUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 15 Feb 2024 (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 object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients on hemodiafiltration with Cytosorb® | – | Device: Cytosorb® and Oxiris® adsorbents |
| Patients on hemodiafiltration with Oxiris® | – | Device: Cytosorb® and Oxiris® adsorbents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult critically ill patients with a diagnosis of SIRS, sepsis and/or septic shock who are hospitalized in the Department of Medical Intensive Care Medicine
Key inclusion criteria (3 listed)
- diagnosis of SIRS, sepsis and/or septic shock,
- older than 18 years, who are being treated with amikacin and/or vancomycin,
- length of use of adsorbent at least 12 hours.
Key exclusion criteria (3 listed)
- contraindication for hemodiafiltration with adsorbents,
- patients under the age of 18,
- terminal cancer patients.
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 |
|---|---|---|
| Cytosorb® and Oxiris® adsorbentsAlso: Drugs' concentrations measurementsThe pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents. | Device | Patients on hemodiafiltration with Cytosorb®, Patients on hemodiafiltration with Oxiris® |
Primary outcome
Development of population pharmacokinetic model
Time frame: One year
Measurement of amikacin and vancomycine serum concentrations in several time points in order to gain pharmacokinetic profiles of previously mentioned drugs and to develop population pharmacokinetic model of amikacin and vancomycin by nonlinear modeling of combined effects in critically ill patients on veno-venous hemodiafiltration with two types of adsorbents.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Nikolina Spiric, MPharm principal investigator
University Clinical Centre of Republic of Srpska
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 Sepsis, run by University Clinical Centre of Republic of Srpska at 1 site in Bosnia and Herzegovina.
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 15 Feb 2024. 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 Bosnia and Herzegovina. 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 Nikolina Spiric, MPharm (+38751342295, nikolina.spiric@kc-bl.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of population pharmacokinetic model (time frame: One year). 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 15 Feb 2024.