Informations générales (source: ClinicalTrials.gov)

NCT02127528 Statut inconnu
Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care: Pharmacodynamic Evaluation and Impact.
Observational
  • Pneumopathie infectieuse
  • Pneumopathie infectieuse sous ventilation assistée
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2014
décembre 2016
09 mai 2026
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.

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH VICTOR DUPOUY ARGENTEUIL Olivier Pajot, MD En recrutement IDF Contact (sur clinicalTrials)
HOPITAL FOCH vendredi 11 mars 2022 Contact (sur clinicalTrials)

Critères

Tous


1. Use of mechanical ventilation for more than 48 hours

2. 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

3. High risk of multidrug-resistant bacteria, defined as either at least 6 days of
mechanical ventilation OR antibiotic treatment in the previous 15 days

4. Implementation of a prior distal respiratory sample for microbiological diagnosis by
bronchoalveolar lavage (BAL) OR distal sampling by protected catheter (PDP)

5. Age ≥ 18 years

6. Implementing a medical examination

7. Obtain the written consent of the patient, one of its relatives or trusted person
previously designated or emergency clause.

Exclusion Criteria:


1. Pregnant woman

2. Expected death within 72 hours of diagnosis of VAP patient

3. Dialysis

4. No affiliation to a social security scheme (beneficiary or legal)

5. 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.