Clinical trial NCT04077697: Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study.
Official title: Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Pulmonary Aspergillosis
Morality
Keywords: invasive pulmonary aspergillosis
Invasive TracheoBronchial Aspergillosis
galactomannan
1,3-β-D-Glucan
influenza
Intensive Care Unit
mortality
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: Centre Hospitalier de Lens
First posted: 2019-09-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for inclusion were 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

Brief summary: Invasive tracheobronchial aspergillosis (ITBA) is an uncommon, but severe clinical form of Invasive Pulmonary Aspergillosis (IPA) in which the fungal infection is entirely or predominantly confined to the tracheobronchial tree. In view of the limited data concerning critically ill patients admitted to the intensive care unit (ICU) with severe influenza associated with ITBA, the investigators decided to evaluate the differences between the clinical presentations of two invasive infections: ITBA and IPA without tracheobronchial involvement (No ITBA).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of management of ITBA diagnosis criteria
timeFrame: from day 0 to two weeks after the start of the study
Secondary outcomes:
measure: Change of management of ITBA prognosis
timeFrame: from day 0 to two weeks after the start of the study
measure: Change of mortality rate between ITBA group and IPA group
timeFrame: from day 0 to two weeks after the start of the study
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Elie Zogheib, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Taieb Chouaki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Hervé Dupont, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Julien Maizel, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Rémy Nyga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Ivona Milic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Lille
name: Saad NSEIR, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Lille
name: Boualem SENDID, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Lens
name: Malcom LEMYSE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nyga R, Maizel J, Nseir S, Chouaki T, Milic I, Roger PA, Van Grunderbeeck N, Lemyze M, Totet A, Castelain S, Slama M, Dupont H, Sendid B, Zogheib E. Invasive Tracheobronchial Aspergillosis in Critically Ill Patients with Severe Influenza. A Clinical Trial. Am J Respir Crit Care Med. 2020 Sep 1;202(5):708-716. doi: 10.1164/rccm.201910-1931OC.