PharmacokineticsPIC-AMINCT03683511
Nomograms for Optimization of Amikacin First Dose in Critically Ill Patients Using a Population Pharmacokinetics Model
An observational study of Pharmacokinetics, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2014to 30 Jun 2016
- 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: Patients treated with amikacin for sepsis ou septic shock in the medical intensive care unit of Nantes,France or in an ICU of Nîmes, France will be recruited.
Who may be able to join
- patients treated with amikacin for sepsis in one of the participating ICU will be included.
Who cannot join
- patients with aminoglycoside allergy, history of myasthenia, pregnancy, under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Population Pharmacokinetics Modeling : a Priori Optimization of Amikacin First Dose in Critically Ill Patients Using a Nomogram
The aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data.
Read the detailed description
French guidelines recommend for probabilistic therapy to reach an amikacin concentration 1 hour after beginning the infusion ≥ 60 mg/L. This target is rarely achieved in the ICU despite a 30 mg/kg recommended dosage. Using data collected prospectively in critically ill patients of Nîmes (France) (1) and Nantes (France), we will elaborate a population pharmacokinetic model on the non-parametric software Pmetrics and on the parametric software Monolix. We will calculate probability of target attainment of Monte-Carlo simulations, using the non-parametric model. Nomograms to determine optimal first dose of amikacin in critically ill patients, according to a few variables previously identified, will be produced.
- Conditions
- Pharmacokinetics
- Keywords
- amikacin
What is being measured
The primary outcome is the main question the study is designed to answer.
amikacin infusion
Target is defined as 8 times x Minimal Inhibatory Concentration for MIC = 4 mg/L and MIC = 8 mg/L. Those PTA will be calculated using the final pharmacokinetics model, according to the dependent variables.
Measured: one hour after beginning of infusion.ed
Secondary outcomes (1)
maximal dose of amikacin (in mg) allowed to have a probability of target attainment (PTA) of 50% or less for the trough concentration.
Target is 2.5 mg/L. Those PTA will be calculated using the final pharmacokinetics model, according to the dependent variables.
Measured: 24 hours after beginning of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start21 Apr 2014
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683511
- Sponsor's protocol ID
- RC14_0121
- Acronym
- PIC-AMI
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roger C, Nucci B, Louart B, Friggeri A, Knani H, Evrard A, Lavigne JP, Allaouchiche B, Lefrant JY, Roberts JA, Muller L. Impact of 30 mg/kg amikacin and 8 mg/kg gentamicin on serum concentrations in critically ill patients with severe sepsis. J Antimicrob Chemother. 2016 Jan;71(1):208-12. doi: 10.1093/jac/dkv291. Epub 2015 Oct 1.
PubMed 26429564
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics Modeling : a Priori Optimization of Amikacin First Dose in Critically Ill Patients Using a Nomogram
- ClinicalTrials.gov ID
- NCT03683511
- Acronym / sponsor ID
- PIC-AMI / RC14_0121
- Conditions
- Pharmacokinetics
- Keywords
- amikacin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Study start
- 21 Apr 2014 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 25 Sep 2018 (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 aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data.
Detailed description
French guidelines recommend for probabilistic therapy to reach an amikacin concentration 1 hour after beginning the infusion ≥ 60 mg/L. This target is rarely achieved in the ICU despite a 30 mg/kg recommended dosage. Using data collected prospectively in critically ill patients of Nîmes (France) (1) and Nantes (France), we will elaborate a population pharmacokinetic model on the non-parametric software Pmetrics and on the parametric software Monolix. We will calculate probability of target attainment of Monte-Carlo simulations, using the non-parametric model. Nomograms to determine optimal first dose of amikacin in critically ill patients, according to a few variables previously identified, will be produced.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with amikacin for sepsis ou septic shock in the medical intensive care unit of Nantes,France or in an ICU of Nîmes, France will be recruited.
Key inclusion criteria (1 listed)
- patients treated with amikacin for sepsis in one of the participating ICU will be included.
Key exclusion criteria (1 listed)
- patients with aminoglycoside allergy, history of myasthenia, pregnancy, under guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
amikacin infusion
Time frame: one hour after beginning of infusion.ed
Target is defined as 8 times x Minimal Inhibatory Concentration for MIC = 4 mg/L and MIC = 8 mg/L. Those PTA will be calculated using the final pharmacokinetics model, according to the dependent variables.
1 secondary outcome
maximal dose of amikacin (in mg) allowed to have a probability of target attainment (PTA) of 50% or less for the trough concentration.
Time frame: 24 hours after beginning of infusion
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 25 Sep 2018.
- Background: PubMed 26429564Roger C, Nucci B, Louart B, Friggeri A, Knani H, Evrard A, Lavigne JP, Allaouchiche B, Lefrant JY, Roberts JA, Muller L. Impact of 30 mg/kg amikacin and 8 mg/kg gentamicin on serum concentrations in critically ill patients with severe sepsis. J Antimicrob Chemother. 2016 Jan;71(1):208-12. doi: 10.1093/jac/dkv291. Epub 2015 Oct 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pharmacokinetics, run by Nantes University Hospital at 1 site in France.
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 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: finished, as of the sponsor's last update on 25 Sep 2018. 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 France. 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?
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?
amikacin infusion (time frame: one hour after beginning of infusion.ed). 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 NCT03683511, which also lists 1 linked publication.
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 25 Sep 2018.