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Clinical Trials/NCT05671328
NCT05671328
Completed
N/A

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

University Hospital, Lille1 site in 1 country263 target enrollmentAugust 28, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ventilator Associated Pneumonia
Sponsor
University Hospital, Lille
Enrollment
263
Locations
1
Primary Endpoint
Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 28, 2023
End Date
July 18, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • 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)
  • Duration of mechanical ventilation(Until discharge from the ICU, an average 28 days)

Study Sites (1)

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