Methicillin-Resistant Staphylococcus AureuSPhase 4NCT01200654
Population Pharmacokinetics of Linezolid
A Phase 4 study testing Linezolid in people with Methicillin-Resistant Staphylococcus AureuS, run by University Hospital, Toulouse.
Trial summary
Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones. It has a specific inhibitory activity against Gram positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methicillin-Resistant Staphylococcus AureuS
- What is being tested?
- Linezolid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Aug 2010
- 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
- In-patient stay in intensive care
- Over 18 years old
- Presenting with MRSA nosocomial pneumonia or bacteraemia with a strain thought to be sensitive to Linezolid
- Simplified Acute Physiological Score (SAPS) II > 20
- Expected duration of life > 7 days.
Who cannot join
- History of allergy to linezolid or any of the antibiotics used
- Isolation of MRSA resistant to linezolid
- Lack of seeds
- Pregnancy and lactation
About this study
Official title: Population Pharmacokinetics of Linezolid in Intensive Care Units Patients Treated for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections
Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones. It has a specific inhibitory activity against Gram positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers. The intensive care units patients, with mechanical ventilation, and with severe sepsis, represent highly heterogeneous population responsible of hight variability in pharmacokinetics parameters (augmentation in total volume of distribution, modification in glomerular filtration) wich can lead to antibiotic inefficacy.
In a first time, this study describe the pharmacokinetics of Linezolid in intensive care units patients with severe MRSA infection. The aim of this study is to define and validate a population pharmacokinetic model including the influence of patients' characteristic on the pharmacokinetics of Linezolid.
Read the detailed description
The demographic, clinical and biological parameters are collected. Patients receive Linezolid as 600 mg twice a day during an administration of 60 minutes.
Blood sampling are collected on the second day after beginning of treatment at the following time : H1, H2, H3, H6 and H12.
The population pharmacokinétics analysis will be carried out using Monolix, a software for the analysis of nonlinear mixed effects models.
- Being tested
- Linezolid
- Keywords
- Population pharmacokinetics, Linezolid, Monolix, nonlinear mixed effects models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidDrug
Also called Pharmacokinetics of Linezolid
Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers
| Study group | Role | What they receive |
|---|---|---|
| MRSA Infections | Experimental | Methicillin-Resistant Staphylococcus aureus Infections Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first objective of this study is to research the influence of patients' characteristic on the pharmacokinetics of Linezolid.
The following demographic, clinical and biological parameters were collected as possible covariates: age, gender, bodyweight, height, etiology of incoming, mechanical ventilation, serum creatinine, proteins, Blood Urea Nitrogen (BUN), leukocyte counts, haemoglobin, C-reactive protein (CRP), and simplified acute physiology scores (SAPS I and II).
Measured: Blood sampling are collected on the second day after begining of treatment at the following time : H1, H2, H3, H6 and H12.
Secondary outcomes (1)
The secondary outcome measure are the verification of the clinical and bactériological efficacies, and to look after the residual concentration
Measured: At the 48th hours of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startNov 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin-Resistant Staphylococcus AureuSStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Georges, PhMD, Principal investigator, UH Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200654
- Sponsor's protocol ID
- 06 049 02
- Status last verified
- Oct 2012
- First submitted
- 10 Sep 2010
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Linezolid in Intensive Care Units Patients Treated for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections
- ClinicalTrials.gov ID
- NCT01200654
- Acronym / sponsor ID
- 06 049 02
- Keywords
- Population pharmacokinetics, Linezolid, Monolix, nonlinear mixed effects models
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 Sep 2010 (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.
Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones. It has a specific inhibitory activity against Gram positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers. The intensive care units patients, with mechanical ventilation, and with severe sepsis, represent highly heterogeneous population responsible of hight variability in pharmacokinetics parameters (augmentation in total volume of distribution, modification in glomerular filtration) wich can lead to antibiotic inefficacy.
In a first time, this study describe the pharmacokinetics of Linezolid in intensive care units patients with severe MRSA infection. The aim of this study is to define and validate a population pharmacokinetic model including the influence of patients' characteristic on the pharmacokinetics of Linezolid.
Detailed description
The demographic, clinical and biological parameters are collected. Patients receive Linezolid as 600 mg twice a day during an administration of 60 minutes.
Blood sampling are collected on the second day after beginning of treatment at the following time : H1, H2, H3, H6 and H12.
The population pharmacokinétics analysis will be carried out using Monolix, a software for the analysis of nonlinear mixed effects models.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRSA Infections | Experimental | Drug: LinezolidMethicillin-Resistant Staphylococcus aureus Infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In-patient stay in intensive care
- Over 18 years old
- Presenting with MRSA nosocomial pneumonia or bacteraemia with a strain thought to be sensitive to Linezolid
- Simplified Acute Physiological Score (SAPS) II > 20
- Expected duration of life > 7 days.
Key exclusion criteria (4 listed)
- History of allergy to linezolid or any of the antibiotics used
- Isolation of MRSA resistant to linezolid
- Lack of seeds
- Pregnancy and lactation
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 |
|---|---|---|
| LinezolidAlso: Pharmacokinetics of LinezolidDosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers | Drug | MRSA Infections |
Primary outcome
The first objective of this study is to research the influence of patients' characteristic on the pharmacokinetics of Linezolid.
Time frame: Blood sampling are collected on the second day after begining of treatment at the following time : H1, H2, H3, H6 and H12.
The following demographic, clinical and biological parameters were collected as possible covariates: age, gender, bodyweight, height, etiology of incoming, mechanical ventilation, serum creatinine, proteins, Blood Urea Nitrogen (BUN), leukocyte counts, haemoglobin, C-reactive protein (CRP), and simplified acute physiology scores (SAPS I and II).
1 secondary outcome
The secondary outcome measure are the verification of the clinical and bactériological efficacies, and to look after the residual concentration
Time frame: At the 48th hours of treatment
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 23 Oct 2012.
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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.
Bernard Georges, PhMD principal investigator
UH Toulouse
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linezolid in people with Methicillin-Resistant Staphylococcus AureuS, run by University Hospital, Toulouse.
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 5 inclusion and 4 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 23 Oct 2012. 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?
The first objective of this study is to research the influence of patients' characteristic on the pharmacokinetics of Linezolid. (time frame: Blood sampling are collected on the second day after begining of treatment at the following time : H1, H2, H3, H6 and H12.). 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 23 Oct 2012.