To Assess the Tissular and Plasma Kinetics of ErtapenemPhase 4NCT00489138
Prospective, Open-label Study of Pharmacokinetics of Ertapenem in the Muscle Using Microdialysis in Mechanically Ventilated Intensive Care Unit Patients, Treated or Not by Norepinephrine
A Phase 4 study testing Ertapenem in people with To Assess the Tissular and Plasma Kinetics of Ertapenem, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Goal of study: To assess the tissular and plasma kinetics of ertapenem; To determine the optimal dosages in the patients according to norepinephrine administration: to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Assess the Tissular and Plasma Kinetics of Ertapenem
- What is being tested?
- Ertapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Apr 2009
- 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
- 18 years and more
- negative pregnancy test
- HIV/HBV, HCV negative tests
- Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem
Who cannot join
- refractory septic shock requiring use of additional catecholamines
- patients with positives tests for HIV, HBV, HCV
- pregnant females
- allergic insufficiency
- hemodiafiltration
- contraindication to microdialysis catheter set-up
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- severe arteritis of lower extremities
- treatment with vasodilatators
- prior history of aorto-iliac shunt
- involvement in a clinical trial in the last three months
- non affiliated to "securité sociale"
Trial locations and contacts
1 site in 1 country.
About this study
Goal of study:
To assess the tissular and plasma kinetics of ertapenem;
To determine the optimal dosages in the patients according to norepinephrine administration:
- to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups "with norepinephrine" or "without norepinephrine" according to their hemodynamic status.
- to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine.
Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).
- Being tested
- Ertapenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
1g a day by drip of 30 min
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Noradrenalin infusion Receives: Drug: Ertapenem |
| 2 | No intervention | No adrenalin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the tissular and plasma kinetics of ertapenem
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2009
- Study completionApr 2009
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 To Assess the Tissular and Plasma Kinetics of ErtapenemStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ioanna BOYADJIEV, PH, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489138
- Sponsor's protocol ID
- 2006/24
- Status last verified
- Feb 2014
- First submitted
- 20 Jun 2007
- Last updated
- 25 Feb 2014
- Results posted
- No
Publications
Boyadjiev I, Boulamery A, Simon N, Martin C, Bruguerolle B, Leone M. Penetration of ertapenem into muscle measured by in vivo microdialysis in mechanically ventilated patients. Antimicrob Agents Chemother. 2011 Jul;55(7):3573-5. doi: 10.1128/AAC.00180-11. Epub 2011 May 16.
PubMed 21576440
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label Study of Pharmacokinetics of Ertapenem in the Muscle Using Microdialysis in Mechanically Ventilated Intensive Care Unit Patients, Treated or Not by Norepinephrine
- ClinicalTrials.gov ID
- NCT00489138
- Acronym / sponsor ID
- 2006/24
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Jun 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.
Goal of study:
To assess the tissular and plasma kinetics of ertapenem;
To determine the optimal dosages in the patients according to norepinephrine administration:
- to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups "with norepinephrine" or "without norepinephrine" according to their hemodynamic status.
- to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine.
Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ErtapenemNoradrenalin infusion |
| 2 | No intervention | –No adrenalin infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and more
- negative pregnancy test
- HIV/HBV, HCV negative tests
- Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem
Key exclusion criteria (11 listed)
- refractory septic shock requiring use of additional catecholamines
- patients with positives tests for HIV, HBV, HCV
- pregnant females
- allergic insufficiency
- hemodiafiltration
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 |
|---|---|---|
| Ertapenem1g a day by drip of 30 min | Drug | 1 |
Primary outcome
assess the tissular and plasma kinetics of ertapenem
Time frame: 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Derived from this study: PubMed 21576440Boyadjiev I, Boulamery A, Simon N, Martin C, Bruguerolle B, Leone M. Penetration of ertapenem into muscle measured by in vivo microdialysis in mechanically ventilated patients. Antimicrob Agents Chemother. 2011 Jul;55(7):3573-5. doi: 10.1128/AAC.00180-11. Epub 2011 May 16.
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.
Ioanna BOYADJIEV, PH principal investigator
Assistance Publique Hôpitaux de Marseille
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 Ertapenem in people with To Assess the Tissular and Plasma Kinetics of Ertapenem, run by Assistance Publique Hopitaux De Marseille 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 11 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: stopped early, as of the sponsor's last update on 25 Feb 2014. 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?
The study was stopped early. 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?
assess the tissular and plasma kinetics of ertapenem (time frame: 24 months). 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 NCT00489138, 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 Feb 2014.