Condition category
Infections and Infestations
Date applied
20/01/2014
Date assigned
21/02/2014
Last edited
27/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Winter hospitalizations for severe acute respiratory infections (SARI) due to an influenza virus have been assessed at University Hospital CHU Mont-Godinne since the 2009 influenza A/H1N1 pandemic wave. All patients presenting to the Emergency Department (ED) are screened according to a SARI case definition. Nasopharyngeal swabs are collected to test for influenza. Recent studies have focused on the role of other respiratory viruses as a cause of illness and death during the winter months. The aims of the study are to assess the impact of influenza and other respiratory viruses during the 2013-2014 winter season, along with the use of internal diagnostic methods in virology.

Who can participate ?
Adult patients matching with the SARI case definition (fever > 38°C or history of fever associated with cough and/or dyspnea (shortness of breath), and requiring hospitalization for more than 24 h), who consent for nasopharyngeal swabbing.

What does the study involve ?
SARI patients will be screened at admission. Nasopharyngeal swabbing is considered as routine practice for SARI patients hospitalized at CHU Mont-Godinne. Infection control measures (transmission-based precautions) are applied as recommended for suspected or documented respiratory viral pathogens. Medical management of patients follows recommendations regarding antiviral treatment for influenza infection, and eventual antibiotic therapy adaptation.

What are the possible benefits and risks of participating ?
The benefits for the patients are the possible initiation of an antiviral treatment for documented influenza infection, and the possible adaptation of antibiotic therapy in case of viral documented infection (influenza and/or another respiratory virus). There are no risks for patients included in the study, as nasopharyngeal swabbing is a non-invasive procedure, and all the medical interventions carried out are same as that performed in standard practice.

Where is the study run from ?
University Hospital Mont-Godinne at Yvoir (Belgium).

When is the study starting and how long is it expected to run for ?
Recruitment started in November 2013 and study will run until April 2014. Participants will be enrolled on the study up to the end of winter period, 2014.

Who is funding the study ?
Mont-Godinne Foundation, Belgium.

Who is the main contact ?
Professor Bénédicte Delaere
Mr Marc Bourgeois, marc.bourgeois@uclouvain.be

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bénédicte Delaere

ORCID ID

Contact details

CHU Mont-Godinne (Catholic University of Louvain)
Infectious Diseases Unit
Av Dr G Therasse 1
Yvoir
5530
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A descriptive observational cohort study to determine the role of respiratory viruses in adult hospitalizations for severe acute respiratory infections (SARI)

Acronym

CHU-SARI

Study hypothesis

It is hypothesized that winter hospitalizations for acute respiratory infections related to viral pathogens are underestimated. Influenza can lead to severe acute infection, but other respiratory viruses may also contribute to morbidity and mortality, especially in adult patients with risk factors.

Ethics approval

CHU Mont-Godinne Ethics Committee, 14/11/2013, ref. BUN 039201318786

Study design

Descriptive observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please contact marc.bourgeois@uclouvain.be to request a patient information sheet

Condition

Infectious diseases/Respiratory viruses/Epidemiology

Intervention

Screening of SARI patients at admission
Nasopharyngeal swabbing
Multiplex rt-PCR for respiratory viruses
Collection and analysis of clinical and epidemiological data

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patients positive for at least one respiratory virus
2. Patients with risk factors

All outcomes measured by prospective and retrospective review of electronic medical charts of enrolled patients (date of admission as baseline, date of discharge, and date of medical hospitalization report completed).

Secondary outcome measures

1. Viral co-infections with two or more respiratory viruses
2. Bacterial co-infections
3. Epidemiology, clinical course and outcome (risk factors, length of stay, complications, intensive care admission, death)
4. Instauration of antiviral treatment following virological diagnosis
5. Adaptation of antibiotic treatment following virological diagnosis

Overall trial start date

15/11/2013

Overall trial end date

15/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult (aged above 16 years)
2. New admission and within 7 days of admission
3. Fever > 38 or history of fever, cough and/or dyspnea
4. Requiring hospitalization for over 24h
5. Oral consent for nasopharyngeal swabbing

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Patients under 16 years of age
2. Patients already hospitalized and developing a SARI

Recruitment start date

15/11/2013

Recruitment end date

15/04/2014

Locations

Countries of recruitment

Belgium

Trial participating centre

CHU Mont-Godinne (Catholic University of Louvain)
Yvoir
5530
Belgium

Sponsor information

Organisation

Mont-Godinne Foundation (Belgium)

Sponsor details

CHU Mont-Godinne (Catholic University of Louvain
Belgium)
Av Dr G. Therasse
1
Yvoir
5530
Belgium

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Mont-Godinne Foundation (Belgium) (CHU Mont-Godinne, Catholic University of Louvain) (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes