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OpenTrials
Completed

NCT Number: NCT05671328

Incidence of Invasive Pulmonary Aspergillosis in 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pôle de Réanimation Hôpital R. Salengro, CHU de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: On the 1 day of inclusion

Secondary outcomes

  1. Incidence of IPA according to the Blot criteria

    Time frame: On the 1 day of inclusion

  2. Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria

    Time frame: On the 1 day of inclusion

  3. Incidence of IPA according to the Verweij criteria in the subgroup without risk factors.

    Time frame: On the 1 day of inclusion

  4. Mortality

    Time frame: at 28 days

  5. Length of stay in intensive care unit

    Time frame: Until discharge from the ICU, an average 28 days

  6. Duration of mechanical ventilation

    Time frame: Until discharge from the ICU, an average 28 days

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: ASPIC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 4, 2023
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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