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

Morality Clinical Trial

— ITBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077697
• Other study ID #: PI2019_843_0047
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: July 16, 2019

Study information

• Verified date: August 2019
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Influenza, Human
• Invasive Pulmonary Aspergillosis
• Morality
• Pulmonary Aspergillosis

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Hospitalier de Lens, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of management of ITBA diagnosis criteria	Evolution of the diagnosis criteria of the ITBA	from day 0 to two weeks after the start of the study
Secondary	Change of management of ITBA prognosis	Evolution of ITBA prognosis	from day 0 to two weeks after the start of the study
Secondary	Change of mortality rate between ITBA group and IPA group	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