Human Epidemiology of Newly Identified Arboviruses | NCT04954352

Studies
Human Epidemiology of Newly Identified Arboviruses

NCT04954352

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Jul 8, 2021Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Arbovirus Infections
SARS-CoV Infection

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 20, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Jul 5, 2021

First Submission Date that Met QC Criteria

Jul 5, 2021

First Posted Date

Jul 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2021

Last Update Posted Date

Jul 8, 2021Actual

Name	Class
UMR ASTRE (CIRAD)	UNKNOWN
Institut Pasteur	INDUSTRY
UMR PCCEI	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Seroprevalence	Detection of antibodies targeting specific antigens of newly identified arboviruses	1 day

Secondary Outcomes

Measure	Description	Time Frame
Molecular detection	Detection of newly identified arboviruses genome	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection with samples available

Exclusion criteria:

- Informed consent non obtain for samples used

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection
Healthy volunteers for seroprevalence investigation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yannick Simonin, PhD	Contact	434359114	33	yannick.simonin@umontpellier.fr
Vincent Foulongne, PhD	Contact	467 330 254	33	v-foulongne@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Vincent Foulongne, PhD	UH MONTPELLIER	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001102	Arbovirus Infections
D045169	Severe Acute Respiratory Syndrome

Ancestor Terms

ID	Term
D000079426	Vector Borne Diseases
D007239	Infections
D014777	Virus Diseases
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided