Invasive Pulmonary Aspergillosis and Severe Influenza (ASPERGIGRIPP)

Is Invasive Pulmonary Aspergillosis a Common Complication of Severe Influenza ?

Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. It remains unknown whether patients with influenza are more at risk of IPA than other patients hospitalized in intensive care unit and whether patients with influenza who develop IPA have specific risk factors for this infection.

Our study aims to determine the incidence of IPA in a large multicenter cohort and to identify risk factors for IPA in these patients.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Influenza; Aspergillosis

• Study Type: Observational
• Enrollment (Actual): 478

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest
  • Morlaix, France
    • CHR
  • Nantes, France, 44000
    • CHU de Nantes
  • Rennes, France, 35033
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with influenza infection

Description

Inclusion Criteria:

• Infection with influenza A or B
• Admission to one of the participating sites

Exclusion Criteria:

• age < 18
• patients with invasive pulmonary aspergillosis prior to intensive care admission
• consent withdraw

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Pulmonary Aspergillosis	incidence of invasive pulmonary aspergillosis	up to 100 days

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Actual): November 5, 2018
• Study Completion (Actual): November 5, 2018

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Orthomyxoviridae Infections; Lung Diseases, Fungal; Influenza, Human; Critical Illness; Aspergillosis; Pulmonary Aspergillosis; Invasive Pulmonary Aspergillosis
• Other Study ID Numbers: ASPERGIGRIPP (29BRC18.0069)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No