SepsisPHARAOHNCT04470973
Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.
An observational study of Sepsis and Septic Shock, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Infection, Bacterial
- What is being tested?
- Cefuroxime and Amikacin
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jul 2020to 15 Dec 2023
- 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: Critically ill patients admitted to the ICU or ED.
Who may be able to join
- The patient is admitted to the ICU or ED;
- The patient is at least 18 years of age on the day of inclusion;
- Is managed with a central venous catheter or arterial line;
- Is treated with amikacin and/or cefuroxime as standard care.
Who cannot join
- 1. Has previously participated in this study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc intensive care
Nijmegen
J Machiels
About this study
Official title: Population Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Septic Patients Admitted to the ICU or the ED
Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU or the ED. To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand the PK of antibiotics in this vulnerable group in order to optimize the dosing regimens.
With this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in ICU and ED patients. A heterogeneous population of ICU and ED patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. By using population modeling the investigators will simulate different dosing regimens and MIC values and compare probability of target attainment between each of these dose and MIC combinations. This will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.
- Conditions
- Sepsis, Septic Shock, Infection, Bacterial, Critically Ill
- Being tested
- Cefuroxime, Amikacin
- Keywords
- Sepsis, Septic Shock, Infection, Critically Ill
- Medical subject headings
- Sepsis, Shock, Septic, Bacterial Infections, Critical Illness, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefuroximeDrug
Patients receive cefuroxime as part of standard care.
AmikacinDrug
Patients receive amikacin as part of standard care.
| Study group | Role | What they receive |
|---|---|---|
| Cefuroxime/Amikacin | 20 patients will be included in the cefuroxime cohort and 20 patients in the amikacin cohort. Receives: Drug: Cefuroxime; Drug: Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients
Measured: 1 year
To describe the population pharmacokinetics of cefuroxime in Intensive Care or Emergency Department patients
Measured: 1 year
Secondary outcomes (3)
To determine the influence of renal clearance and weight on the pharmacokinetics of amikacin and cefuroxime
Measured: 1 year
To determine the proportion of patients who attain adequate PK/PD targets in relation to the MIC of the suspected pathogen.
Measured: 1 year
To determine the toxicity of amikacin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start15 Jul 2020
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (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.
- More trials run by Radboud University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger Brüggemann, Phd, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470973
- Sponsor's protocol ID
- PHARAOH
- Acronym
- PHARAOH
- Status last verified
- Sep 2022
- First submitted
- 9 Jul 2020
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Septic Patients Admitted to the ICU or the ED
- ClinicalTrials.gov ID
- NCT04470973
- Acronym / sponsor ID
- PHARAOH / PHARAOH
- Conditions
- Sepsis, Septic Shock, Infection, Bacterial, Critically Ill
- Keywords
- Sepsis, Septic Shock, Infection, Critically Ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 14 Jul 2020 (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.
Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU or the ED. To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand the PK of antibiotics in this vulnerable group in order to optimize the dosing regimens.
With this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in ICU and ED patients. A heterogeneous population of ICU and ED patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. By using population modeling the investigators will simulate different dosing regimens and MIC values and compare probability of target attainment between each of these dose and MIC combinations. This will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefuroxime/Amikacin | – | Drug: Cefuroxime, Drug: Amikacin20 patients will be included in the cefuroxime cohort and 20 patients in the amikacin cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to the ICU or ED.
Key inclusion criteria (4 listed)
- The patient is admitted to the ICU or ED;
- The patient is at least 18 years of age on the day of inclusion;
- Is managed with a central venous catheter or arterial line;
- Is treated with amikacin and/or cefuroxime as standard care.
Key exclusion criteria (1 listed)
- 1. Has previously participated in this study.
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 |
|---|---|---|
| CefuroximePatients receive cefuroxime as part of standard care. | Drug | Cefuroxime/Amikacin |
| AmikacinPatients receive amikacin as part of standard care. | Drug | Cefuroxime/Amikacin |
Primary outcome
To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients
Time frame: 1 year
To describe the population pharmacokinetics of cefuroxime in Intensive Care or Emergency Department patients
Time frame: 1 year
3 secondary outcomes
To determine the influence of renal clearance and weight on the pharmacokinetics of amikacin and cefuroxime
Time frame: 1 year
To determine the proportion of patients who attain adequate PK/PD targets in relation to the MIC of the suspected pathogen.
Time frame: 1 year
To determine the toxicity of amikacin
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: Undecided
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.
Roger Brüggemann, Phd principal investigator
Radboud University Medical Center
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 and Septic Shock, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 inclusion and 1 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 Sep 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 Netherlands. 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 Julian Machiels, MD, MSc (+31243614369, julian.machiels@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients (time frame: 1 year). The study lists 2 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 Sep 2022.