- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077697
Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study. (ITBA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Invasive pulmonary aspergillosis (IPA) is a well-known complication in severely immunocompromised hosts patients. Recent evidence has identified others populations at risk for IPA, including those with chronic obstructive pulmonary disease (COPD) and advanced cirrhosis patients in intensive care units (ICUs). Moreover, Recently influenza has been identified as a new independent risk factor for IPA and IPA was described as an early complication of influenza. IPA groups different clinical presentations: the classical angio-invasive, the broncho-invasive form and the invasive tracheobronchitis aspergillosis form (ITBA).
ITBA is an infrequent clinical form of IPA with often a fatal outcome, in which Aspergillus infection involves entirely or predominantly the tracheobronchial tree. Early diagnosis of ITBA is based on bronchoscopy examination. Severe influenza is a life-threatening condition where IPA has been repeatedly reported. Little is known on severe influenza infection complicated with IPA and still less with ITBA. Current data on ITBA in critically ill patients hospitalized for severe influenza infection has only been described in single case reports. Because ITBA has been associated with a poorer prognostic than other forms of IPA, this retrospective study aimed to analyze diagnostic and prognostic differences between ITBA and IPA without tracheobronchial lesions, in critically ill patients with influenza infection hospitalized in ICU.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Amiens, France, 80054
- CHU Amiens
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all ICU (Intensive care unit) patients
- patients aged from 18 years and more
- All patients hospitalized in ICU with a positive influenza RT-PCR extracted from the registry of the local virology department
- patients with a diagnosis of influenza confirmed by a positive influenza real time polymerase chain reaction (RT-PCR) from nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid, with a concomitant diagnosis of proven or probable/putative IPA and the performing of a bronchoscopy
Exclusion Criteria:
- minor or adult with guardianship
- absence of hospitalization in intensive care
- influenza infection not confirmed by PCR
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ITBA group
ITBA group is : invasive tracheobronchitis aspergillosis form.
|
influenza real time polymerase chain reaction (RT-PCR) from a nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid.
|
IPA without tracheobronchial involvement
IPA group is : invasive pulmonary aspergillosis without tracheobronchial involvement
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influenza real time polymerase chain reaction (RT-PCR) from a nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of management of ITBA diagnosis criteria
Time Frame: from day 0 to two weeks after the start of the study
|
Evolution of the diagnosis criteria of the ITBA
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from day 0 to two weeks after the start of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of management of ITBA prognosis
Time Frame: from day 0 to two weeks after the start of the study
|
Evolution of ITBA prognosis
|
from day 0 to two weeks after the start of the study
|
Change of mortality rate between ITBA group and IPA group
Time Frame: from day 0 to two weeks after the start of the study
|
ITBA group is : invasive tracheobronchitis aspergillosis form.
IPA group is : invasive pulmonary aspergillosis without tracheobronchial involvement
|
from day 0 to two weeks after the start of the study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hervé Dupont, Pr, CHU Amiens
- Principal Investigator: Julien Maizel, Pr, CHU Amiens
- Principal Investigator: Rémy Nyga, MD, CHU Amiens
- Principal Investigator: Ivona Milic, MD, CHU Amiens
- Principal Investigator: Saad NSEIR, Pr, CHU Lille
- Principal Investigator: Boualem SENDID, Pr, CHU Lille
- Principal Investigator: Malcom LEMYSE, MD, CHU Lens
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Invasive Fungal Infections
- Orthomyxoviridae Infections
- Lung Diseases, Fungal
- Influenza, Human
- Aspergillosis
- Pulmonary Aspergillosis
- Invasive Pulmonary Aspergillosis
Other Study ID Numbers
- PI2019_843_0047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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