Pulmonary Aspergillosis Invasive, Ventilator Associated Pneumonia
Conditions
Keywords
Pulmonary invasive aspergillosis, ventilator-associated-pneumonia, mechanical ventilation, nosocomial infections
Brief summary
Mechanically ventilated patients are at risk of developing ventilator-associated pneumonia (VAP). Invasive pulmonary aspergillosis (IPA), the diagnosis of which motivates the implementation of specific treatments, is one of the causes of VAP. The hypothesis of the study is that the incidence of IPA is 12.4%. For each patient presenting with a suspicion of VAP and requiring a bronchoalveolar lavage (BAL), the diagnosis of API will be evaluated by biological examinations performed on blood and BAL. Medical and surgical history as well as clinical and biological data will be collected for 28 days or until discharge from the ICU.
Interventions
OTHERBiological examinations performed on blood and BAL
Direct examination and culture of BAL Galactomannan in serum and BAL Serum 1,3 beta D glucans Aspergillus PCR in BAL
Sponsors
Pfizer
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (age ≥ 18 years), * On invasive ventilation for more than 48 hours, * Suspected VAP, defined by the appearance or worsening of a radiological pulmonary infiltrate, associated with 2 of the following clinical criteria: * Fever ≥ 38° C or hypothermia ≤ 36.5° C * Leukocytes \> 12x109 or \< 4x109/L * Purulent tracheal secretions
Exclusion criteria
* Neutropenic patients (neutrophils \< 0.5G/L), * Previous diagnosis of IPA, * Minor patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP | On the 1 day of inclusion |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria | On the 1 day of inclusion |
| Incidence of IPA according to the Verweij criteria in the subgroup without risk factors. | On the 1 day of inclusion |
| Incidence of IPA according to the Blot criteria | On the 1 day of inclusion |
| Length of stay in intensive care unit | Until discharge from the ICU, an average 28 days |
| Duration of mechanical ventilation | Until discharge from the ICU, an average 28 days |
| Mortality | at 28 days |
Countries
France
Outcome results
None listed