Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia (ASPIC)

December 18, 2025 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

263

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Pôle de Réanimation Hôpital R. Salengro, CHU de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in ICU

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected ventilator-associated pneumonia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP
Time Frame: On the 1 day of inclusion
On the 1 day of inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: at 28 days
at 28 days
Incidence of IPA according to the Blot criteria
Time Frame: On the 1 day of inclusion
On the 1 day of inclusion
Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria
Time Frame: On the 1 day of inclusion
On the 1 day of inclusion
Incidence of IPA according to the Verweij criteria in the subgroup without risk factors.
Time Frame: On the 1 day of inclusion
On the 1 day of inclusion
Length of stay in intensive care unit
Time Frame: Until discharge from the ICU, an average 28 days
Until discharge from the ICU, an average 28 days
Duration of mechanical ventilation
Time Frame: Until discharge from the ICU, an average 28 days
Until discharge from the ICU, an average 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Pfizer

Investigators

  • Principal Investigator: Saad NSEIR, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Actual)

July 18, 2025

Study Completion (Actual)

July 18, 2025

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_0061
  • 2022-A00496-37 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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