NCT03757546

Brief Summary

The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza virus and Respiratory Syncitial Virus infections in hospitalized adults at a French university hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

December 3, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2019

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

October 17, 2018

Last Update Submit

February 6, 2020

Conditions

InfluenzaRespiratory Virus SyncitialExtra-respiratory

Outcome Measures

Primary Outcomes (1)

  • Evaluation frequency of extra-respiratory manifestations with clinical, biological and radiological data

    * Clinical data (clinical examination) * Biological Data (blood test) * Radiological data

    at 1 month

Interventions

observationalOTHER

The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.

Eligibility Criteria

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

adults hospitalized with flu or RSV infections

You may qualify if:

  • Hospitalized adults ≥18 years old
  • Flu or RSV infection confirmed by multiplex qPCR on nasal swab
  • Oral non-opposition

You may not qualify if:

  • No health insurance
  • Co-infection with viruses other than influenza or RSV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

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

Study Record Dates

First Submitted

October 17, 2018

First Posted

November 29, 2018

Study Start

December 3, 2018

Primary Completion

March 14, 2019

Study Completion

April 14, 2019

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations

FR(1)