Overview

Impact of Imipenem With Amikacin Pharmacokinetic and Pharmacodynamic

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
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 therapy, impact microbiological and clinical outcome of patients with Gram negative bacilli (GNB) ventilator-associated pneumonia (VAP).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Amikacin
Imipenem
Criteria
Inclusion Criteria:

1. Age ≥ 18 years

2. Mechanical ventilation for more than 48 hours

3. 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

4. Risk of multi resistant bacteria defined as follows: at least 6 days of mechanical
ventilation or antibiotic treatment in the 15 previous days

5. Distal pulmonary secretion sample obtained beforehand for microbiological diagnosis by
bronchoalveolar lavage via bronchoscopy or blinded protected telescoping catheter via
bronchoscopy or blindly

6. Presence of GNB on direct examination of the distal pulmonary secretion sample

7. 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 Criteria:

1. Time between distal pulmonary secretion sample taking and the 1st administration of
imipenem exceeding 24 hours

2. Pregnancy

3. Severely impaired renal function (creatinine clearance lower than 10 mL/mn or renal
replacement therapy)

4. Allergy to imipenem or amikacin

5. Treatment in progress with imipenem or amikacin

6. Death expected within 48 hours following diagnosis of VAP

7. Myasthenia

8. Simultaneous administration of others aminoglycosides

9. Association with intravenous polymyxin or botulinum toxin