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

NCT ID: NCT04077697

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-07-16

Brief Summary

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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

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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.

Conditions

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Invasive Pulmonary Aspergillosis Morality

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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ITBA group

ITBA group is : invasive tracheobronchitis aspergillosis form.

RT-PCR for influenza

Intervention Type DIAGNOSTIC_TEST

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

RT-PCR for influenza

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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RT-PCR for influenza

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role collaborator

Centre Hospitalier de Lens

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elie Zogheib, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Taieb Chouaki, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Hervé Dupont, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Julien Maizel, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Rémy Nyga, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Ivona Milic, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Saad NSEIR, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Lille

Boualem SENDID, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Lille

Malcom LEMYSE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Lens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

References

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Nyga R, Maizel J, Nseir S, Chouaki T, Milic I, Roger PA, Van Grunderbeeck N, Lemyze M, Totet A, Castelain S, Slama M, Dupont H, Sendid B, Zogheib E. Invasive Tracheobronchial Aspergillosis in Critically Ill Patients with Severe Influenza. A Clinical Trial. Am J Respir Crit Care Med. 2020 Sep 1;202(5):708-716. doi: 10.1164/rccm.201910-1931OC.

Reference Type DERIVED
PMID: 32407157 (View on PubMed)

Other Identifiers

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PI2019_843_0047

Identifier Type: -

Identifier Source: org_study_id

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