ASPIC: Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05671328
Collaborator
Pfizer (Industry)
261
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Biological examinations performed on blood and BAL

Study Design

Study Type:
Observational
Anticipated Enrollment :
261 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Incidence of Invasive Pulmonary Aspergillosis in Patients With Suspected Ventilator-associated Pneumonia
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Incidence of IPA according to the Blot criteria [On the 1 day of inclusion]

  2. Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria [On the 1 day of inclusion]

  3. Incidence of IPA according to the Verweij criteria in the subgroup without risk factors. [On the 1 day of inclusion]

  4. Mortality [at 28 days]

  5. Length of stay in intensive care unit [Until discharge from the ICU, an average 28 days]

  6. Duration of mechanical ventilation [Until discharge from the ICU, an average 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Lille
  • Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT05671328
Other Study ID Numbers:
  • 2022_0061
  • 2022-A00496-37
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 4, 2023
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Lille
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2023