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.

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Collaborator: University Hospital, Lille
Centre Hospitalier de Lens

Source Centre Hospitalier Universitaire, Amiens
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.

Overall Status Completed
Start Date July 1, 2019
Completion Date July 16, 2019
Primary Completion Date July 16, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Change of management of ITBA diagnosis criteria from day 0 to two weeks after the start of the study
Secondary Outcome
Measure Time Frame
Change of management 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 from day 0 to two weeks after the start of the study
Enrollment 35
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: RT-PCR for influenza

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

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: CHU Amiens
Location Countries

France

Verification Date

August 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: ITBA group

Description: ITBA group is : invasive tracheobronchitis aspergillosis form.

Label: IPA without tracheobronchial involvement

Description: IPA group is : invasive pulmonary aspergillosis without tracheobronchial involvement

Acronym ITBA
Patient Data No
Study Design Info

Observational Model: Case-Only

Time Perspective: Retrospective

Source: ClinicalTrials.gov