Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Incidence of Invasive Pulmonary Aspergillosis in Patients With Suspected Ventilator-associated Pneumonia

Conditions
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Ventilator Associated Pneumonia, Pulmonary Aspergillosis Invasive

Intervention / Treatment
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* Other: Biological examinations performed on blood and BAL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspected ventilator-associated pneumonia<br> | Other: Biological examinations performed on blood and BAL<br>* Direct examination and culture of BAL Galactomannan in serum and BAL Serum 1,3 beta D glucans Aspergillus PCR in BAL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of IPA according to the Blot criteria |  | On the 1 day of inclusion | 
| 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 | 
| Mortality |  | at 28 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary invasive aspergillosis, ventilator-associated-pneumonia, mechanical ventilation, nosocomial infections