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

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00489138
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
To Assess the Tissular and Plasma Kinetics of Ertapenem	Drug: Ertapenem	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Noradrenalin infusion	Drug: Ertapenem; 1g a day by drip of 30 min
No Intervention: 2 No adrenalin infusion

Outcome Measures

Primary Outcome Measures

1. assess the tissular and plasma kinetics of ertapenem [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years and more

• negative pregnancy test

• HIV/HBV, HCV negative tests

• Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem

Exclusion Criteria:

• 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

• exclusion from national records

• non affiliated to "securité sociale"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Département d'Anesthésie-Réanimation - CHU NORD	Marseille		France	13915

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Principal Investigator: Ioanna BOYADJIEV, PH, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT00489138
• Other Study ID Numbers: 2006/24
• First Posted: Jun 21, 2007
• Last Update Posted: Feb 25, 2014
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Ertapenem

Study Results

No Results Posted as of Feb 25, 2014