Suspected Infection With Vancomycin Susceptible Bacterial StrainsPK-VANCO-ICUNCT02844192
Pharmacokinetics of Vancomycin in ICU Patients
An observational study of Suspected Infection With Vancomycin Susceptible Bacterial Strains, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution, vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin underdosing in ICU patients, among others. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Infection With Vancomycin Susceptible Bacterial Strains
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Aug 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: ICU patients
Who may be able to join
- patient hospitalized in intensive care unit
- under intravenous vancomycin started during current ICU hospitalization
- with at least one vancomycin serum concentration available
- under hemodynamic monitoring with the Picco ® device
Who cannot join
- vancomycin treatment for less than 24 hours
- vancomycin concentration in serum unavailable
- rare comorbidities influencing vancomycin pharmacokinetics
- myeloma
- cystic fibrosis
- burn injury on more than 20 % of the body surface
- previous inclusion in present study
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire,103 Grande Rue de la Croix-Rousse
Lyon, 69004
About this study
Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution, vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin underdosing in ICU patients, among others.
To date, bedside estimation of vancomycin volume of distribution is challenging, and new methods for optimizing drug administration are required.
Read more
The Picco device is a moderately invasive hemodynamic monitoring system, providing parameters that may help estimation of vancomycin pharmacokinetics parameter.
The aim of this study is to test whether addition of hemodynamic parameters would improve pharmacokinetics modelling of vancomycin concentration in ICU patients.
- Keywords
- Vancomycin, under dosage, intensive care unit, pharmacokinetics
What is being measured
The primary outcome is the main question the study is designed to answer.
Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration
All available vancomycin measurements during the first week of treatment will be included in the pharmacokinetics model.
All vancomycin dosages up to seven days of treatment will be used in a population pharmacokinetic model and an individual pharmacokinetic model
Measured: week 1
Secondary outcomes (1)
Rate of patients with under-dosage of vancomycin at day 2 of treatment
under-dosage of vancomycin is defined by a vancomycin serum concentration below 15 mg/l on day 2 of treatment.
Measured: day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Infection With Vancomycin Susceptible Bacterial StrainsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe RICHARD, Prof, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844192
- Sponsor's protocol ID
- 69HCL16_0452
- Acronym
- PK-VANCO-ICU
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Vancomycin in ICU Patients
- ClinicalTrials.gov ID
- NCT02844192
- Acronym / sponsor ID
- PK-VANCO-ICU / 69HCL16_0452
- Keywords
- Vancomycin, under dosage, intensive care unit, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 26 Jul 2016 (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.
Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution, vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin underdosing in ICU patients, among others.
To date, bedside estimation of vancomycin volume of distribution is challenging, and new methods for optimizing drug administration are required.
The Picco device is a moderately invasive hemodynamic monitoring system, providing parameters that may help estimation of vancomycin pharmacokinetics parameter.
The aim of this study is to test whether addition of hemodynamic parameters would improve pharmacokinetics modelling of vancomycin concentration in ICU patients.
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
- ICU patients
Key inclusion criteria (4 listed)
- patient hospitalized in intensive care unit
- under intravenous vancomycin started during current ICU hospitalization
- with at least one vancomycin serum concentration available
- under hemodynamic monitoring with the Picco ® device
Key exclusion criteria (7 listed)
- vancomycin treatment for less than 24 hours
- vancomycin concentration in serum unavailable
- rare comorbidities influencing vancomycin pharmacokinetics
- previous inclusion in present study
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
Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration
Time frame: week 1
All available vancomycin measurements during the first week of treatment will be included in the pharmacokinetics model. All vancomycin dosages up to seven days of treatment will be used in a population pharmacokinetic model and an individual pharmacokinetic model
1 secondary outcome
Rate of patients with under-dosage of vancomycin at day 2 of treatment
Time frame: day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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.
Jean-Christophe RICHARD, Prof principal investigator
Hospices Civils de Lyon
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 Suspected Infection With Vancomycin Susceptible Bacterial Strains, run by Hospices Civils de Lyon 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 4 inclusion and 7 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 26 Jul 2016. 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?
Results are not available in the source record.
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?
Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration (time frame: week 1). 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 26 Jul 2016.