Arbovirus InfectionsARBODOCCNCT04954352
Human Epidemiology of Newly Identified Arboviruses
An observational study of Arbovirus Infections and SARS-CoV Infection, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A local network is being set up to study the impact of arboviruses in our region. It is committed to a one-health approach, in particular with research without a priori for new viruses hosted among vectors and wildlife. Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Arbovirus Infections, SARS-CoV Infection
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 30 Dec 2024
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection * Healthy volunteers for seroprevalence investigation
Who may be able to join
- Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection with samples available
Who cannot join
- Informed consent non obtain for samples used
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
Vincent Foulongne, PHD, 467 330 254 ext. 33, v-foulongne@chu-montpellier.fr
Sérafin Guttierez
About this study
Official title: Epidemiology in Humans of New Arbovirusus Sorted Out From Metagenomic Screen in Local Vectors and Animal Hosts.
A local network is being set up to study the impact of arboviruses in our region. It is committed to a one-health approach, in particular with research without a priori for new viruses hosted among vectors and wildlife. The candidates identified by high throughput sequencing approaches will serve as a basis for the development of serological and molecular tools for their detections. These tools will be used to assess the possible circulation of these new viruses in humans in biological collections created within the framework of this project Arbodocc
.
- Conditions
- Arbovirus Infections, SARS-CoV Infection
- Keywords
- Patients with arboviral infection compatible signs, Unexplained isolated fever, Neurological infection conditions without any identified etiology, Arbovirus, Arboviral like infectious disease
- Medical subject headings
- Arbovirus Infections, Severe Acute Respiratory Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence
Detection of antibodies targeting specific antigens of newly identified arboviruses
Measured: 1 day
Secondary outcomes (1)
Molecular detection
Detection of newly identified arboviruses genome
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jan 2020
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- UMR ASTRE (CIRAD), Institut Pasteur, UMR PCCEI
- Responsible party
- Sponsor
- Investigators
- Vincent Foulongne, PhD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954352
- Sponsor's protocol ID
- RECHMPL21_0297
- Acronym
- ARBODOCC
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology in Humans of New Arbovirusus Sorted Out From Metagenomic Screen in Local Vectors and Animal Hosts.
- ClinicalTrials.gov ID
- NCT04954352
- Acronym / sponsor ID
- ARBODOCC / RECHMPL21_0297
- Conditions
- Arbovirus Infections, SARS-CoV Infection
- Keywords
- Patients with arboviral infection compatible signs, Unexplained isolated fever, Neurological infection conditions without any identified etiology, Arbovirus, Arboviral like infectious disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- UMR ASTRE (CIRAD), Institut Pasteur, UMR PCCEI
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Jul 2021 (actual)
- 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.
A local network is being set up to study the impact of arboviruses in our region. It is committed to a one-health approach, in particular with research without a priori for new viruses hosted among vectors and wildlife. The candidates identified by high throughput sequencing approaches will serve as a basis for the development of serological and molecular tools for their detections. These tools will be used to assess the possible circulation of these new viruses in humans in biological collections created within the framework of this project Arbodocc
.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection * Healthy volunteers for seroprevalence investigation
Key inclusion criteria (1 listed)
- Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection with samples available
Key exclusion criteria (1 listed)
- Informed consent non obtain for samples used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Seroprevalence
Time frame: 1 day
Detection of antibodies targeting specific antigens of newly identified arboviruses
1 secondary outcome
Molecular detection
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Vincent Foulongne, PhD study director
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arbovirus Infections and SARS-CoV Infection, run by University Hospital, Montpellier 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick Simonin, PhD (434359114 ext. 33, yannick.simonin@umontpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence (time frame: 1 day). 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 8 Jul 2021.