NCT04232956

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
478

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

July 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

July 10, 2018

Last Update Submit

January 15, 2020

Conditions

AspergillosisInfluenzaCritical Illness

Outcome Measures

Primary Outcomes (1)

  • Invasive Pulmonary Aspergillosis

    incidence of invasive pulmonary aspergillosis

    up to 100 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients with influenza infection

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHRU de Brest

Brest, 29609, France

Location

CHR

Morlaix, France

Location

CHU de NANTES

Nantes, 44000, France

Location

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

AspergillosisInfluenza, HumanCritical Illness

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

January 18, 2020

Study Start

July 27, 2018

Primary Completion

November 5, 2018

Study Completion

November 5, 2018

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)