NCT04615364

Brief Summary

Arboviruses, diseases transmitted to humans by the bite of an insect vector, are a major public health problem, especially in tropical and sub-tropical countries. A promising strategy aimed at blocking the circulation of arboviruses is to release Aedes aegypti mosquitoes carrying the endosymbiotic bacterium Wolbachia. In 2019, the Wolbachia strategy was implemented in Nouméa as part of the World Mosquito Program. This intervention will modify the epidemiological profile of arboviruses in New Caledonia. Epidemiological surveillance of arboviruses requires molecular characterization of the virus contained in the serum obtained from the blood collected from patients. This molecular characterization by RNA isolation techniques, RT-qPCR monitoring and sequencing allows the construction of phylogenetic trees. In the context of the implementation of the World Mosquito Program in Nouméa, the investigators plan to follow the molecular evolution of arboviruses, over the period preceding the releases of mosquitoes carrying Wolbachia (from 1995 to 2019) then over a period of 5 years. following the releases. At the same time, the virus can be isolated by cell culture techniques and in vitro infections, allowing its study in vitro in cells or in vivo in mosquitoes. This study allows us to measure the impact of the Wolbachia strategy on the evolution of the virus's ability to replicate in cells in the presence of Wolbachia and to be transmitted by the mosquito.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2025

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

5 years

First QC Date

October 29, 2020

Last Update Submit

May 22, 2024

Conditions

Arbovirus InfectionsDengueZikaChikungunya

Keywords

New Caledonia

Outcome Measures

Primary Outcomes (2)

  • arbovirus genome sequencing

    Whole genome sequencing of virus extracted of blood samples from patients collected from 1995 to 2024

    5 years

  • genetic evolution of arbovirus strains

    bioinformatical analysis of the genome of the strains of arbovirus contained in serum samples collected from 1995 to 2024

    5 years

Secondary Outcomes (2)

  • measurement of the impact of Wolbachia on the virus genetic evolution

    5 years

  • measurement of the ability of these viruses to replicate in the presence of Wolbachia

    5 years

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient infected by arboviruses

You may qualify if:

  • Appearance of clinical signs suggestive of an infection with an arbovirus in the 7 days preceding the blood sample,
  • Diagnostic confirmation by RT-qPCR of mono-infection with dengue virus or another arbovirus.
  • Patients or their representative (s) informed of the possible secondary use for research purposes of the samples initially taken for diagnostic purposes and their derivatives, and who have not since expressed their opposition to the secondary use of the samples diagnostics or their derivatives for research,

You may not qualify if:

  • Documented opposition from a patient or his representative (s)
  • Previously established viral load too low.
  • Sample obtained from a sample taken more than 7 days after the appearance of clinical signs of infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Territorial

Dumbéa Sur Mer, Nouvelle-Calédonie, 98 835, France

RECRUITING

Related Publications (1)

  • Inizan C, Minier M, Prot M, O'Connor O, Forfait C, Laumond S, Marois I, Biron A, Gourinat AC, Goujart MA, Descloux E, Sakuntabhai A, Tarantola A, Simon-Loriere E, Dupont-Rouzeyrol M. Viral evolution sustains a dengue outbreak of enhanced severity. Emerg Microbes Infect. 2021 Dec;10(1):536-544. doi: 10.1080/22221751.2021.1899057.

    PMID: 33686914DERIVED

MeSH Terms

Conditions

Arbovirus InfectionsDengueZika Virus InfectionChikungunya Fever

Condition Hierarchy (Ancestors)

Vector Borne DiseasesInfectionsVirus DiseasesMosquito-Borne DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralAlphavirus InfectionsTogaviridae Infections

Study Officials

  • Myrielle Dupont-Rouzeyrol, PhD

    Institut Pasteur de Nouvelle-Calédonie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myrielle Dupont-Rouzeyrol, PhD

CONTACT

+687 27 75 30mdupont@pasteur.nc

Catherine Inizan, PhD

CONTACT

+687 27 26 66cinizan@pasteur.fr

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

July 17, 2020

Primary Completion

July 17, 2025

Study Completion

July 17, 2025

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations

FR(1)