Status:
COMPLETED
Impact of Imipenem With Amikacin Pharmacokinetic and Pharmacodynamic
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Ventilator Associated Pneumonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a prospective open trial conducted in 4 centers, and designed to determine if pharmacokinetic (PK) and pharmacodynamic (PD) parameters of imipenem, associated with amikacin as empirical t...
Detailed Description
Inappropriate initial antibiotherapy increases mortality of many serious infections. This is the case for ventilator-associated pneumonia, frequently occurring during intensive care unit (ICU) hospita...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Mechanical ventilation for more than 48 hours
- Clinical suspicion of VAP defined by a new persistent radiological infiltrate and one of the following signs: purulent tracheal aspirations, or temperature of 38°3 or higher, or leucocyte count \> 10000/ml
- Risk of multi resistant bacteria defined as follows: at least 6 days of mechanical ventilation or antibiotic treatment in the 15 previous days
- Distal pulmonary secretion sample obtained beforehand for microbiological diagnosis by bronchoalveolar lavage via bronchoscopy or blinded protected telescoping catheter via bronchoscopy or blindly
- Presence of GNB on direct examination of the distal pulmonary secretion sample
- Realization of a preliminary medical examination. 8- Written inform consent from the patient or relatives. The consent may be obtained after the enrollment if the patient is not able to give consent and if there is no relatives
Exclusion
- Time between distal pulmonary secretion sample taking and the 1st administration of imipenem exceeding 24 hours
- Pregnancy
- Severely impaired renal function (creatinine clearance lower than 10 mL/mn or renal replacement therapy)
- Allergy to imipenem or amikacin
- Treatment in progress with imipenem or amikacin
- Death expected within 48 hours following diagnosis of VAP
- Myasthenia
- Simultaneous administration of others aminoglycosides
- Association with intravenous polymyxin or botulinum toxin
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00950222
Start Date
June 1 2009
End Date
January 1 2012
Last Update
July 26 2012
Active Locations (1)
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1
Victor Dupouy Hospital
Argenteuil, France, 95100