Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia

Ventilator Associated Pneumonia Clinical Trial

— ASPIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05671328
• Other study ID #: 2022_0061
• Secondary ID: 2022-A00496-37
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: March 2025

Study information

• Verified date: August 2022
• Source: University Hospital, Lille
• Contact: Saad NSEIR, MD,PhD
• Phone: 0320445962
• Email: saadalla.NSEIR[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 261
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Pulmonary Aspergillosis
• Pneumonia
• Pneumonia, Ventilator-Associated
• Pulmonary Aspergillosis
• Ventilator Associated Pneumonia

Intervention

Other:
• Biological 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP		On the 1 day of inclusion
Secondary	Incidence of IPA according to the Blot criteria		On the 1 day of inclusion
Secondary	Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria		On the 1 day of inclusion
Secondary	Incidence of IPA according to the Verweij criteria in the subgroup without risk factors.		On the 1 day of inclusion
Secondary	Mortality		at 28 days
Secondary	Length of stay in intensive care unit		Until discharge from the ICU, an average 28 days
Secondary	Duration of mechanical ventilation		Until discharge from the ICU, an average 28 days