Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care

NCT02127528 | Unknown

• 1 other identifier: P1101137
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• adequate antibiotics

  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)

  28 days

Secondary Outcomes (7)

• Bacterial species

  28 days

• Distribution of the main pharmacodynamic parameters

  28 days

• Eradication of gram negative bacilli responsible for VAP

  28 days

• Death

  28 days

• Number of days alive without mechanical ventilation

  28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pneumonia acquired in mechanically ventilated patients (PAVM)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant woman
• Expected death within 72 hours of diagnosis of VAP patient
• Dialysis
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CH Victor Dupouy

Argenteuil, Val d'Oise, 95100, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Olivier Pajot, MD

CONTACT

+33 1 34 23 24 51; olivier.pajot@ch-argenteuil.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: April 30, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

FR (1)