Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care: Pharmacodynamic Evaluation and Impact.

Assistance Publique - Hôpitaux de Paris1 site in 1 country500 target enrollmentMay 2014

ConditionsVentilator-associated Pneumonia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Ventilator-associated Pneumonia
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 500
Locations: 1
Primary Endpoint: adequate antibiotics
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

this study aims to verify the adequacy of doses of antibiotics prescribed in clinical practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact of these pharmacodynamic parameters on the clinical and microbiological VAP will be evaluated.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

December 2016

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Use of mechanical ventilation for more than 48 hours
•Clinical suspicion of ventilation-acquired pneumonia (VAP) defined by new radiological persisting infiltrate (or ARDS) AND one of the following features:
•purulent tracheal aspirates OR temperature ≥ 38.3°C OR leukocytosis\> 10 giga/L
•High risk of multidrug-resistant bacteria, defined as either at least 6 days of mechanical ventilation OR antibiotic treatment in the previous 15 days
•Implementation of a prior distal respiratory sample for microbiological diagnosis by bronchoalveolar lavage (BAL) OR distal sampling by protected catheter (PDP)
•Age ≥ 18 years
•Implementing a medical examination
•Obtain the written consent of the patient, one of its relatives or trusted person previously designated or emergency clause.

Exclusion Criteria

•Pregnant woman
•Expected death within 72 hours of diagnosis of VAP patient
•No affiliation to a social security scheme (beneficiary or legal)
•Contraindication to one of classes of molecules used antibiotics (β-lactam / Fluoroquinolones / Aminoglycosides), contained in the Summary of Product Characteristics for authorization on the market.

Outcomes

Primary Outcomes

adequate antibiotics

Time Frame: 28 days

proportion of patients for whom the pharmacodynamic target defined a priori according to data from the literature is reached for each antibiotic anti Gram-negative bacillus used empirically activity (including β-lactams, fluoroquinolones and aminoglycosides)