SepsisPhase 4PORTHOSNCT00449800
Pharmacokinetic of Ceftriaxone in Septic ICU Patients
A Phase 4 study testing ceftriaxone in people with Sepsis and Severe Sepsis, run by Association Pour La Promotion A Tours De La Reanimation Medicale at 1 site in France.
Trial summary
Ceftriaxone pharmacokinetics variability in intensive care unit septic patients In intensive care units, drug dosage is often based on study made on healthy volunteers or on less severe patients. However, pharmacokinetic alterations have been described for some drugs used in intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis, Septic Shock
- What is being tested?
- ceftriaxone
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2006to Mar 2007
- 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
- Eighteen-year or more
- sepsis, severe sepsis or septic shock (according to Bone's criteria)
- admission to intensive care unit
- informed consent obtained
- affiliation to medicare
Who cannot join
- Previous haemodialysis
- hemopathy
- known allergy to cephalosporin
- patients whose death is considered imminent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cenrte Hospitalier Régional Universitaire
Tours, 37044
DENIS GAROT, MD
About this study
Official title: Pharmacokinetics Variability of Ceftriaxone in Septic ICU Patients
Ceftriaxone pharmacokinetics variability in intensive care unit septic patients
In intensive care units, drug dosage is often based on study made on healthy volunteers or on less severe patients.
Read more
However, pharmacokinetic alterations have been described for some drugs used in intensive care units.
These alterations, consequences of alteration of volume of distribution, of protein concentrations, of impaired hepatic and renal functions can result in accumulation with toxicity or " under dosage " with inefficacity.
Ceftriaxone is an antibiotic often prescribed in intensive care unit. However, despite this large utilisation, very few data is available on the pharmacokinetic in intensive care unit, and optimal dosage is not known.
Our objective is to develop a population pharmacokinetics model of ceftriaxone in intensive care unit patients with sepsis, severe sepsis and septic shock and to identify the " data " explaining interindividual variability of each pharmacokinetics parameter.
Read the detailed description
This is a one centre population pharmacokinetics non interventional study. One group of 50 patients allows the development of the model and a second group of 20 patients will be used for the validation of the model.
Septic patients treated with ceftriaxone according to standard procedure of our ICU could be included before the second administration of the drug. In the development group, patients will underwent five determination of serum concentration of ceftriaxone during the 24 hours following the second administration. The timing of samples will be randomised in three groups. A second phase of sampling will take place during the fifth day of ceftriaxone therapy for sepsis and severe sepsis patients and after 48 hours catecholamine- free for septic shock patients.
For the validation group, ten samples will be obtained at the same periods. This study will not induce any change in the care of patients.
Samples will be centrifugated immediately after collection and conserved at - 20 °C.
Ceftriaxone will be assayed in the department of pharmacology, university of Marseille France, usig HPLC method.
Pharmacokinetic analysis will used NONlinear Mixed Effects Modelling logiciel
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Being tested
- ceftriaxone
- Keywords
- Sepsis, Ceftriaxone, Pharmacokinetic, Intensive care unit
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
serum drug concentration
pharmacokinetics parameter (plasmatic half-life, clearance, ...)
ratio of serum drug concentration on MCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startJul 2006
- Study completionMar 2007 (estimated)
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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Association Pour La Promotion A Tours De La Reanimation Medicale
- Sponsor type
- University, hospital or other
- Investigators
- DENIS GAROT, MD, Principal investigator, CHRU TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449800
- Sponsor's protocol ID
- APTRM 2006-02
- Acronym
- PORTHOS
- Status last verified
- Mar 2007
- First submitted
- 14 Mar 2007
- Last updated
- 21 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Garot D, Respaud R, Lanotte P, Simon N, Mercier E, Ehrmann S, Perrotin D, Dequin PF, Le Guellec C. Population pharmacokinetics of ceftriaxone in critically ill septic patients: a reappraisal. Br J Clin Pharmacol. 2011 Nov;72(5):758-67. doi: 10.1111/j.1365-2125.2011.04005.x.
PubMed 21545483
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Variability of Ceftriaxone in Septic ICU Patients
- ClinicalTrials.gov ID
- NCT00449800
- Acronym / sponsor ID
- PORTHOS / APTRM 2006-02
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Keywords
- Sepsis, Ceftriaxone, Pharmacokinetic, Intensive care unit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants
- Lead sponsor
- Association Pour La Promotion A Tours De La Reanimation MedicaleUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Mar 2007 (estimated)
- First posted
- 21 Mar 2007 (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.
Ceftriaxone pharmacokinetics variability in intensive care unit septic patients
In intensive care units, drug dosage is often based on study made on healthy volunteers or on less severe patients.
However, pharmacokinetic alterations have been described for some drugs used in intensive care units.
These alterations, consequences of alteration of volume of distribution, of protein concentrations, of impaired hepatic and renal functions can result in accumulation with toxicity or " under dosage " with inefficacity.
Ceftriaxone is an antibiotic often prescribed in intensive care unit. However, despite this large utilisation, very few data is available on the pharmacokinetic in intensive care unit, and optimal dosage is not known.
Our objective is to develop a population pharmacokinetics model of ceftriaxone in intensive care unit patients with sepsis, severe sepsis and septic shock and to identify the " data " explaining interindividual variability of each pharmacokinetics parameter.
Detailed description
This is a one centre population pharmacokinetics non interventional study. One group of 50 patients allows the development of the model and a second group of 20 patients will be used for the validation of the model.
Septic patients treated with ceftriaxone according to standard procedure of our ICU could be included before the second administration of the drug. In the development group, patients will underwent five determination of serum concentration of ceftriaxone during the 24 hours following the second administration. The timing of samples will be randomised in three groups. A second phase of sampling will take place during the fifth day of ceftriaxone therapy for sepsis and severe sepsis patients and after 48 hours catecholamine- free for septic shock patients.
For the validation group, ten samples will be obtained at the same periods. This study will not induce any change in the care of patients.
Samples will be centrifugated immediately after collection and conserved at - 20 °C.
Ceftriaxone will be assayed in the department of pharmacology, university of Marseille France, usig HPLC method.
Pharmacokinetic analysis will used NONlinear Mixed Effects Modelling logiciel
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eighteen-year or more
- sepsis, severe sepsis or septic shock (according to Bone's criteria)
- admission to intensive care unit
- informed consent obtained
- affiliation to medicare
Key exclusion criteria (4 listed)
- Previous haemodialysis
- hemopathy
- known allergy to cephalosporin
- patients whose death is considered imminent
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 |
|---|---|---|
| ceftriaxone | Drug | – |
Primary outcome
serum drug concentration
pharmacokinetics parameter (plasmatic half-life, clearance, ...)
ratio of serum drug concentration on MCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2007.
- Derived from this study: PubMed 21545483Garot D, Respaud R, Lanotte P, Simon N, Mercier E, Ehrmann S, Perrotin D, Dequin PF, Le Guellec C. Population pharmacokinetics of ceftriaxone in critically ill septic patients: a reappraisal. Br J Clin Pharmacol. 2011 Nov;72(5):758-67. doi: 10.1111/j.1365-2125.2011.04005.x.
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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.
DENIS GAROT, MD principal investigator
CHRU TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ceftriaxone in people with Sepsis and Severe Sepsis, run by Association Pour La Promotion A Tours De La Reanimation Medicale 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 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: status not confirmed, as of the sponsor's last update on 21 Mar 2007. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DENIS GAROT, MD (+33 2 47 47 38 55, garot@med.univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum drug concentration. The study lists 3 primary outcomes in all. 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 NCT00449800, 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 21 Mar 2007.