InfluenzaNCT00263900
TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit
A study testing RSV respi-strip and Quick-vue influenza in people with Influenza and Respiratory Syncytial Viruses, run by University Hospital, Rouen at 4 sites in France.
Trial summary
The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Influenza, Respiratory Syncytial Viruses
- What is being tested?
- RSV respi-strip and Quick-vue influenza
- Type of treatment
- Medical device
- How many people
- 377 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2005to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age less than 5 years
- Isolated fever and/or
- Infection of the higher air routes (congestive otitis, feverish rhinitides, tracheitis or laryngitis) and/or infection of the lower air routes (cough, pneumonia, bronchitis, asthma)
- Signed consent form
Who cannot join
- Evocative clinical of a urinary and/or bacterial infection
- Purulent acute otitis media
- Typical acute bronchiolitis
- Suspicion of acute lobar pneumonia
- Acute gastro-enteritis
- Anginas
Show all 10Show fewer
- Serious chronic respiratory pathology
- Other infection whose etiologic viral diagnosis is established
- Congenital or acquired immunizing deficits
- Congenital cardiopathy
Trial locations and contacts
4 sites in 1 country.
France4 sites
Urgences pédiatriques
Amiens
Urgences pédiatriques CHU de Caen
Caen, 14033
POSU pediatrique
Le Havre, 76083
Urgences pédiatriques - CHU ROUEN
Rouen, 76031
About this study
Official title: Exploratory Study of the Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit and Their Impact on the Assumption of Responsibility of the Suspect Children of a Viral Infection
The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit.
- Conditions
- Influenza, Respiratory Syncytial Viruses
- Being tested
- RSV respi-strip and Quick-vue influenza
- Keywords
- Influenza A, Influenza B, RSV
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV respi-strip and Quick-vue influenzaDevice
Assessments of 2 quick diagnostic tests in the emergency unit during children's care
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessments of quick diagnostic test of the Influenza virus and the SRV to measure the utility and the impact of those tests on the care of children in emergency unit
Measured: time of support at the emergnecy unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionMay 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Investigators
- Christophe MARGUET, Professor, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263900
- Sponsor's protocol ID
- 2004/078/HP
- Status last verified
- Apr 2011
- First submitted
- 8 Dec 2005
- Last updated
- 21 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit and Their Impact on the Assumption of Responsibility of the Suspect Children of a Viral Infection
- ClinicalTrials.gov ID
- NCT00263900
- Acronym / sponsor ID
- 2004/078/HP
- Conditions
- Influenza, Respiratory Syncytial Viruses
- Keywords
- Influenza A, Influenza B, RSV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age less than 5 years
- Isolated fever and/or
- Infection of the higher air routes (congestive otitis, feverish rhinitides, tracheitis or laryngitis) and/or infection of the lower air routes (cough, pneumonia, bronchitis, asthma)
- Signed consent form
Key exclusion criteria (10 listed)
- Evocative clinical of a urinary and/or bacterial infection
- Purulent acute otitis media
- Typical acute bronchiolitis
- Suspicion of acute lobar pneumonia
- Acute gastro-enteritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV respi-strip and Quick-vue influenzaAssessments of 2 quick diagnostic tests in the emergency unit during children's care | Device | – |
Primary outcome
Assessments of quick diagnostic test of the Influenza virus and the SRV to measure the utility and the impact of those tests on the care of children in emergency unit
Time frame: time of support at the emergnecy unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe MARGUET, Professor principal investigator
University Hospital, Rouen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSV respi-strip and Quick-vue influenza in people with Influenza and Respiratory Syncytial Viruses, run by University Hospital, Rouen at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessments of quick diagnostic test of the Influenza virus and the SRV to measure the utility and the impact of those tests on the care of children in emergency unit (time frame: time of support at the emergnecy unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2011.