Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia

Not yet recruiting

• Conditions: Pulmonary Aspergillosis Invasive; Ventilator Associated Pneumonia
• Interventions: Other: Biological examinations performed on blood and BAL

• Registration Number: NCT05671328
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2023-01-02
• Last Update Submitted: 2023-01-02
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04
• Study Start: 2023-03
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 261

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with suspected ventilator-associated pneumonia	Biological examinations performed on blood and BAL	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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