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
1 other identifier
interventional
9
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFebruary 25, 2014
February 1, 2014
2 years
June 20, 2007
February 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
assess the tissular and plasma kinetics of ertapenem
24 months
Study Arms (2)
1
EXPERIMENTALNoradrenalin infusion
2
NO INTERVENTIONNo adrenalin infusion
Interventions
Eligibility Criteria
You may qualify if:
- years and more
- negative pregnancy test
- HIV/HBV, HCV negative tests
- Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem
You may not qualify if:
- 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
- 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"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Département d'Anesthésie-Réanimation - CHU NORD
Marseille, 13915, France
Related Publications (1)
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.
PMID: 21576440DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ioanna BOYADJIEV, PH
Assistance Publique Hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 21, 2007
Study Start
April 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
February 25, 2014
Record last verified: 2014-02