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

NCT04077697 | Completed

• 1 other identifier: PI2019_843_0047
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Invasive Pulmonary Aspergillosis; Morality

Keywords

invasive pulmonary aspergillosis; Invasive TracheoBronchial Aspergillosis; galactomannan; 1,3-β-D-Glucan; influenza; Intensive Care Unit; mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

ITBA group

ITBA group is : invasive tracheobronchitis aspergillosis form.

Diagnostic Test: RT-PCR for influenza

IPA without tracheobronchial involvement

IPA group is : invasive pulmonary aspergillosis without tracheobronchial involvement

Diagnostic Test: RT-PCR for influenza

Interventions

RT-PCR for influenza DIAGNOSTIC_TEST

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

IPA without tracheobronchial involvement; ITBA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for inclusion were 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

You may qualify if:

• 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

You may not qualify if:

• minor or adult with guardianship
• absence of hospitalization in intensive care
• influenza infection not confirmed by PCR

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• University Hospital, Lille: collaborator
• Centre Hospitalier de Lens: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Related Publications (1)

• 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.

  PMID: 32407157 DERIVED

Biospecimen

Retention: NONE RETAINED

Nasopharyngeal swab

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis; Influenza, Human

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Elie Zogheib, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Taieb Chouaki, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Hervé Dupont, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Julien Maizel, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Rémy Nyga, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Ivona Milic, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Saad NSEIR, Pr

  CHU Lille

  PRINCIPAL INVESTIGATOR

• Boualem SENDID, Pr

  CHU Lille

  PRINCIPAL INVESTIGATOR

• Malcom LEMYSE, MD

  CHU Lens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: September 4, 2019
• Study Start: July 1, 2019
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)