Summer Febrile Syndromes of Viral OriginNCT00842166
Surveillance of Summer Febrile Syndromes of Viral Origin in South of France
A study testing BLOOD DRAW in people with Summer Febrile Syndromes of Viral Origin, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The aim is to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France in order to better understand the role of known vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the arthropod vector. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Summer Febrile Syndromes of Viral Origin
- What is being tested?
- BLOOD DRAW
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Jul 2011
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Old: equal to or higher than 5 years Living in the south of France, without voyage abroad in the 2 weeks preceding inclusion Presenting a fever or a syndrome pseudogripal since less than 7 days without diagnostic orientation nor infectious pathology of body,
- Affiliated with a mode of social security
- After obtaining free and informed of the written assent
Who cannot join
- Subject whose adhesion with the protocol is improbable according to the investigator
- Expectant mother
- Subject taking part in another clinical trial or in period of exclusion of a preceding clinical trial infectious
- Pathology of body requiring a specific treatment
- Discovered after inclusion d' a pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Maladies Infectieuses et Tropicales de l'Hôpital Nord, AP-HM
Marseille
About this study
The aim is to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France in order to better understand the role of known vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the arthropod vector. In each of the four cities, a network of general practitioners will be associated in the project to recruit patients who are not hospitalized. The combined involvement of infectious disease specialists and general practitioner will augment the range of patients (mild disease and sever cases) in the study.
- Conditions
- Summer Febrile Syndromes of Viral Origin
- Being tested
- BLOOD DRAW
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOOD DRAWOther
specific interview, sequential blood collection to allow virus isolation, molecular and serological diagnostics in patients
What is being measured
The primary outcome is the main question the study is designed to answer.
to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France
Measured: 3 years
Secondary outcomes (1)
Identification and characterization of emergent viruses responsible for estival fever in the south of France
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Summer Febrile Syndromes of Viral OriginStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- REMI CHARREL, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842166
- Sponsor's protocol ID
- 2008 19
- Other IDs
- 2008-A00793-52
- Status last verified
- Aug 2014
- First submitted
- 11 Feb 2009
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Summer Febrile Syndromes of Viral Origin in South of France
- ClinicalTrials.gov ID
- NCT00842166
- Acronym / sponsor ID
- 2008 19
- Conditions
- Summer Febrile Syndromes of Viral Origin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Feb 2009 (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 is to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France in order to better understand the role of known vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the arthropod vector. In each of the four cities, a network of general practitioners will be associated in the project to recruit patients who are not hospitalized. The combined involvement of infectious disease specialists and general practitioner will augment the range of patients (mild disease and sever cases) in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Old: equal to or higher than 5 years Living in the south of France, without voyage abroad in the 2 weeks preceding inclusion Presenting a fever or a syndrome pseudogripal since less than 7 days without diagnostic orientation nor infectious pathology of body,
- Affiliated with a mode of social security
- After obtaining free and informed of the written assent
Key exclusion criteria (5 listed)
- Subject whose adhesion with the protocol is improbable according to the investigator
- Expectant mother
- Subject taking part in another clinical trial or in period of exclusion of a preceding clinical trial infectious
- Pathology of body requiring a specific treatment
- Discovered after inclusion d' a pregnancy
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 |
|---|---|---|
| BLOOD DRAWspecific interview, sequential blood collection to allow virus isolation, molecular and serological diagnostics in patients | Other | – |
Primary outcome
to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France
Time frame: 3 years
1 secondary outcome
Identification and characterization of emergent viruses responsible for estival fever in the south of France
Time frame: 3years
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 29 Aug 2014.
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.
REMI CHARREL principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLOOD DRAW in people with Summer Febrile Syndromes of Viral Origin, run by Assistance Publique Hopitaux De Marseille at 1 site 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 3 inclusion and 5 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 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France (time frame: 3 years). 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 29 Aug 2014.