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Trial record 54 of 201 for:    aspergillosis

Influenza Associated Aspergillosis In-depth Investigation (PIAS)

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ClinicalTrials.gov Identifier: NCT03748069
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU.

Condition or disease
Influenza With Pneumonia Invasive Pulmonary Aspergillosis

Detailed Description:

This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU, and correlate findings with occurrence of secondary invasive pulmonary aspergillosis infection.

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.


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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unraveling the Pathogenesis of Influenza-associated Aspergillosis: a Single-center, Prospective Cohort Pilot Study
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Influenza positive CAPIV
All consecutive patients older than 18 years, admitted to the ICU with respiratory distress with microbiologically confirmed diagnosis of influenza
Influenza negative CAPIV
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



Primary Outcome Measures :
  1. Difference in immune cell profile in blood between influenza and non-influenza CAPIV patients at ICU. [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    Immunophenotyping of blood will be performed to determine number of neutrophils, T- and B-cell subsets, NK cell and myeloid cell subsets. Difference in influenza positive and influenza negative patients is expected.

  2. Difference in cytokine production of mononuclear cells to fungal stimulation in blood between influenza and non-influenza CAPIV patients at ICU. [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    Key cytokine reaction of mononuclear cells (PBMC) after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.

  3. Difference in function of blood neutrophils between influenza and non-influenza CAPIV patients at ICU. [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    Functional analysis by killing assay will be performed.

  4. Difference in in immune cell profile in BAL fluid between influenza and non-influenza CAPIV patients at ICU. [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    Immunophenotyping of BAL fluid will be performed to determine number of neutrophils, T- and B-cell subsets, NK cell and myeloid cell subsets. Difference in influenza positive and influenza negative patients is expected.

  5. Difference in cytokine production of mononuclear cells to fungal stimulation in BAL fluid between influenza and non-influenza CAPIV patients at ICU. [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    Key cytokine reaction of mononuclear BAL fluid cells after fungal stimulation will be performed. Difference in influenza positive and influenza negative patients is expected.

  6. Difference in function of BAL fluid neutrophils between influenza and non-influenza CAPIV patients at ICU. [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    Functional analysis by killing assay will be performed.

  7. Difference in pathological hallmarks between influenza and non-influenza CAPIV patients at ICU. [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    Biopsies of respiratory tract tissue will be compared between two groups.


Secondary Outcome Measures :
  1. Difference in longitudinal alterations in phagocytic cell and mononuclear inflammatory cell subsets in blood and BAL fluid and their response to fungal stimulation between the main study arms. [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    Longitudinal alterations in advanced immunophenotyping results and (fungal) cell stimulation will be analysed and compared between groups.

  2. Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    Respiratory tract biopsies will be compared longitudinally throughout the disease course.

  3. Correlation of findings with invasive pulmonary aspergillosis incidence [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    All data will be compared within each group between patients that develop IPA vs no development of IPA.

  4. Correlation of findings with outcome [ Time Frame: through study completion, after 3 influenza seasons (3 years) ]
    All data will be compared to outcome measures (length of ICU stay, mortality, etc) to find hallmarks of severe disease.


Biospecimen Retention:   Samples With DNA
whole blood, serum, white cells, broncho-alveolar lavage fluid, lung tissue


Information from the National Library of Medicine

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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
Critically ill community-acquired pneumonia patients
Criteria

Inclusion Criteria:

  • All patients older than 18 years, admitted to ICU with respiratory distress with microbiologically confirmed diagnosis of influenza (for inclusion in the influenza group)
  • All 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 years old
  • Pregnant women
  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748069


Contacts
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Contact: Joost Wauters, PhD 16344275 ext +32 joost.wauters@uzleuven.be
Contact: Lore Vanderbeke, MD 16344275 ext +32 lore.vanderbeke@uzleuven.be

Locations
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Belgium
Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Belgium, 3000
Contact: Joost Wauters, PhD    16344275 ext +32    joost.wauters@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Joost Wauters, PhD UZ LEUVEN

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03748069     History of Changes
Other Study ID Numbers: PIAS
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Universitaire Ziekenhuizen Leuven:
Influenza
IPA
ICU
Immunology

Additional relevant MeSH terms:
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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