Invasive Pulmonary Aspergillosis Complicating Influenza Infection

NCT03391492 | Completed

• 1 other identifier: Basilicum
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 2

Brief Summary

Study the incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients with severe influenza and in influenza-negative control patients with severe community-acquired pneumonia

Conditions

Influenza With Pneumonia; Aspergillosis Invasive

Keywords

ICU

Outcome Measures

Primary Outcomes (1)

• incidence IPA between ICU patients with severe influenza and in influenza-negative control patients

  incidence of mycological evidence of Aspergillus and at least one Aspergillus compatible sign or symptom and radiological abnormalities based on Chest CT or Chest X ray. Mycological evidence can be provided by either (A) a positive culture of Aspergillus cultured from bronchoalveolar lavage (BAL) sample, (B) ≥2 positive cultures of Aspergillus cultured from a sputum or a bronchial aspirate or (C) a galactomannan (GM) optical density of ≥1 in BAL or ≥0.5 in serum. Aspergillus compatible signs or symptoms are defined as at least one of the following: * Worsening respiratory insufficiency in spite of proper antibiotic and ventilator support * Dyspnea * Haemoptysis * Fever refractory to at least 3 days of appropriate antibiotic (AB) therapy. Recrudescent fever after a period of defervescence of at least 48 h while still on AB without apparent cause. The presence of hyphae in lung biopsy or autopsy are also considered as sufficient evidence for IPA.

  from date of admission in ICU assessed up to ICU discharge, approximately 21 days

Secondary Outcomes (3)

• variations in baseline factors and risk factors between influenza and non-influenza patients in ICU

  from date of admission in ICU to date of ICU discharge, approximately 21 days

• rate of IPA disease progression

  from date of admission to ICU to date of discharge from ICU, approximately 21 days

• rate of presence of azole resistance

  from date of admission to ICU to date of discharge from ICU, approximately 21 days

Study Arms (2)

influenza group

All consecutive patients older than 18 years ,admitted to the ICU with respiratory distress with microbiologically confirmed diagnosis of influenza

control group

All consecutive patients older than 18 years, admitted to the ICU for respiratory distress due to community-acquired pneumonia (CAP) and with a microbiologically confirmed absence of influenza,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients admitted from home to ICU with respiratory distress, with documented pulmonary infiltrates and initiation of antimicrobial therapy because community acquired pneumonia is the primary diagnosis or in the differential diagnosis. Confirmation of presence or absence of influenza is based on probe-based reverse-transcriptase polymerase chain reaction (RT-PCR) for influenza A or B directly on sputum, bronchial aspirate, broncho-alveolar (BAL) fluid or a nasopharyngeal swab.

You may not qualify if:

• age \< 18 year
• no informed consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (2)

AZ sint Jan

Bruges, 8000, Belgium

Location

Jessa AH

Hasselt, 3500, Belgium

Location

Study Officials

• Joost Wauters, Phd

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: January 5, 2018
• Study Start: January 20, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Locations

BE (2)