Skip to main content
OpenTrials
Completed

NCT Number: NCT04077697

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

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).

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RT-PCR for influenza

Diagnostic Test

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

Primary outcomes

  1. Change of management of ITBA diagnosis criteria

    Time frame: from day 0 to two weeks after the start of the study

    Evolution of the diagnosis criteria of the ITBA

Secondary outcomes

  1. Change of management of ITBA prognosis

    Time frame: from day 0 to two weeks after the start of the study

    Evolution of ITBA prognosis

  2. Change of mortality rate between ITBA group and IPA group

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Centre Hospitalier de Lens
  • University Hospital, Lille

Registry information

Acronym: ITBA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2019
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.