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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT04077697

Collaborator

University Hospital, Lille (Other), Centre Hospitalier de Lens (Other)

Enrollment

Location

Actual Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Invasive Pulmonary Aspergillosis Morality	Diagnostic Test: RT-PCR for influenza

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 Design

Study Type:

Observational

Actual Enrollment :

35 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2019

Actual Primary Completion Date :

Jul 16, 2019

Actual Study Completion Date :

Jul 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
ITBA group ITBA group is : invasive tracheobronchitis aspergillosis form.	Diagnostic Test: RT-PCR for influenza 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	Diagnostic Test: RT-PCR for influenza influenza real time polymerase chain reaction (RT-PCR) from a nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid.

Arm

Intervention/Treatment

ITBA group

ITBA group is : invasive tracheobronchitis aspergillosis form.

Diagnostic Test: RT-PCR for influenza

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

Diagnostic Test: RT-PCR for influenza

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

Outcome Measures

Primary Outcome Measures

Change of management of ITBA diagnosis criteria [from day 0 to two weeks after the start of the study]
Evolution of the diagnosis criteria of the ITBA

Secondary Outcome Measures

Change of management of ITBA prognosis [from day 0 to two weeks after the start of the study]
Evolution of ITBA prognosis
Change of mortality rate between ITBA group and IPA group [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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