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Trial record 14 of 26 for:    Recruiting, Not yet recruiting, Available Studies | "Aspergillosis"

Invasive Pulmonary Aspergillosis Complicating Influenza Infection

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ClinicalTrials.gov Identifier: NCT03391492
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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 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 : March 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


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,



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



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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

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

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): NCT03391492


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

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03391492     History of Changes
Other Study ID Numbers: Basilicum
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: December 2017
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
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Invasive Fungal Infections