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Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia

NCT ID: NCT05671328

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

263 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-28

Study Completion Date

2025-07-18

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.

Detailed Description

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Conditions

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Ventilator Associated Pneumonia Pulmonary Aspergillosis Invasive

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with suspected ventilator-associated pneumonia

Biological examinations performed on blood and BAL

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saad NSEIR, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Pôle de Réanimation Hôpital R. Salengro, CHU de Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2022-A00496-37

Identifier Type: OTHER

Identifier Source: secondary_id

2022_0061

Identifier Type: -

Identifier Source: org_study_id