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Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study.

Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04077697
Acronym
ITBA
Enrollment
35
Registered
2019-09-04
Start date
2019-07-01
Completion date
2019-07-16
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Pulmonary Aspergillosis, Morality

Keywords

invasive pulmonary aspergillosis, Invasive TracheoBronchial Aspergillosis, galactomannan, 1,3-β-D-Glucan, influenza, Intensive Care Unit, mortality

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.

Interventions

DIAGNOSTIC_TESTRT-PCR for influenza

influenza real time polymerase chain reaction (RT-PCR) from a nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid.

Sponsors

University Hospital, Lille
CollaboratorOTHER
Centre Hospitalier de Lens
CollaboratorOTHER
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of management of ITBA diagnosis criteriafrom day 0 to two weeks after the start of the studyEvolution of the diagnosis criteria of the ITBA

Secondary

MeasureTime frameDescription
Change of management of ITBA prognosisfrom day 0 to two weeks after the start of the studyEvolution of ITBA prognosis
Change of mortality rate between ITBA group and IPA groupfrom day 0 to two weeks after the start of the studyITBA group is : invasive tracheobronchitis aspergillosis form. IPA group is : invasive pulmonary aspergillosis without tracheobronchial involvement

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026