Invasive Pulmonary Aspergillosis Complicating Influenza Infection

• ClinicalTrials.gov Identifier: NCT03391492
• Recruitment Status: Recruiting
• First Posted: January 5, 2018
• Last Update Posted: April 28, 2021
• Sponsor: Universitaire Ziekenhuizen Leuven
• Information provided by (Responsible Party): Universitaire Ziekenhuizen Leuven

Study Description

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

Condition or disease
Influenza With Pneumonia; Aspergillosis Invasive

Detailed Description:

This prospective multicentre case-control registration study in Dutch and Belgian ICUs will assess the difference in incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients with severe influenza compared with influenza-negative control patients with severe community-acquired pneumonia during the coming three influenza seasons (2017-2020). The study will further assess the differences in clinical characteristics and risk factors between influenza patients with and without invasive aspergillosis.

All consecutive patients aged 18 or older admitted to ICU during the inclusion period with respiratory distress due to influenza positive/negative community acquired pneumonia (CAP) will be included.

Study Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Invasive Pulmonary Aspergillosis Complicating Influenza Infection in Critically Ill Patients: a Prospective, Observational, Multicenter Case Control Registration Study
• Actual Study Start Date: January 20, 2018
• Estimated Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: June 30, 2021

Groups and Cohorts

Group/Cohort
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,

Outcome Measures

Primary Outcome Measures :

1. incidence IPA between ICU patients with severe influenza and in influenza-negative control patients [ Time Frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days ]

   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.

Secondary Outcome Measures :

1. variations in baseline factors and risk factors between influenza and non-influenza patients in ICU [ Time Frame: from date of admission in ICU to date of ICU discharge, approximately 21 days ]
   difference in baseline factors: demographic, biochemical, microbiological and radiological data
2. rate of IPA disease progression [ Time Frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days ]
   rate of IPA disease progression in the subgroup of patients with IPA
3. rate of presence of azole resistance [ Time Frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days ]
   rate of presence of azole resistance in the subgroup of patients with IPA

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

Inclusion Criteria:

• patient older than 18 years,admitted to ICU with respiratory distress with microbiologically confirmed diagnosis of influenza (for inclusion in the influenza group)
• patients older than 18 years, admitted to ICU for respiratory distress due to community-acquired pneumonia , with a microbiologically confirmed absence of influenza (for inclusion in the control group)

Exclusion Criteria:

• age < 18 year
• no informed consent

Contacts and Locations

Contacts

Contact: Joost Wauters, Phd; +3216344275; joost.wauters@uzleuven.be

Locations

Belgium

AZ sint Jan; Recruiting

Brugge, Belgium, 8000

Contact: Marc Bourgeois, PhD

Contact: Joke Denolf, SC

Jessa AH; Recruiting

Hasselt, Belgium, 3500

Contact: Petere Messiaen, Phd

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

• Principal Investigator: Joost Wauters, Phd; UZ Leuven

More Information

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT03391492
• Other Study ID Numbers: Basilicum
• First Posted: January 5, 2018
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitaire Ziekenhuizen Leuven:

ICU

Additional relevant MeSH terms:

Aspergillosis; Pulmonary Aspergillosis; Invasive Pulmonary Aspergillosis; Influenza, Human; Pneumonia; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Mycoses; Lung Diseases, Fungal; Invasive Fungal Infections