Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia

NCT05671328 | Completed

• 2 other identifiers: 2022_00612022-A00496-37
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia; Pulmonary Aspergillosis Invasive

Keywords

Pulmonary invasive aspergillosis; ventilator-associated-pneumonia; mechanical ventilation; nosocomial infections

Outcome Measures

Primary Outcomes (1)

• Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP

  On the 1 day of inclusion

Secondary Outcomes (6)

• 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

Study Arms (1)

Patients with suspected ventilator-associated pneumonia

Other: Biological examinations performed on blood and BAL

Interventions

Biological examinations performed on blood and BAL OTHER

Direct examination and culture of BAL Galactomannan in serum and BAL Serum 1,3 beta D glucans Aspergillus PCR in BAL

Patients with suspected ventilator-associated pneumonia

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

Patients hospitalized in ICU

You may qualify if:

• 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

You may not qualify if:

• Neutropenic patients (neutrophils \< 0.5G/L),
• Previous diagnosis of IPA,
• Minor patients.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Pfizer: collaborator

Study Sites (1)

Pôle de Réanimation Hôpital R. Salengro, CHU de Lille

Lille, France

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Invasive Pulmonary Aspergillosis; Cross Infection

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Invasive Fungal Infections; Lung Diseases, Fungal

Study Officials

• Saad NSEIR, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 4, 2023
• Study Start: August 28, 2023
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)