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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04615364
Other study ID # 2019-022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 17, 2020
Est. completion date July 17, 2025

Study information

Verified date May 2024
Source Institut Pasteur
Contact Myrielle Dupont-Rouzeyrol, PhD
Phone +687 27 75 30
Email mdupont@pasteur.nc
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Collection of blood samples from patients with arbovirus infection This study is a non-interventional study with retrospective part. This study will improve : - the assessment of the molecular evolution of arboviruses in the period preceding the implementation of the Wolbachia strategy - the knowledge of the impact of Wolbachia on the diversity and molecular evolution of arboviruses - the understanding of arbovirus transmission and replication mechanisms in the presence of Wolbachia


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date July 17, 2025
Est. primary completion date July 17, 2025
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: - 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, Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier Territorial Dumbéa Sur Mer Nouvelle-Calédonie

Sponsors (3)

Lead Sponsor Collaborator
Institut Pasteur Centre Hospitalier Territorial de Nouvelle-Calédonie, Institut Pasteur de Nouvelle-Calédonie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary arbovirus genome sequencing Whole genome sequencing of virus extracted of blood samples from patients collected from 1995 to 2024 5 years
Primary 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 measurement of the impact of Wolbachia on the virus genetic evolution comparison of viral genomes extracted from blood samples collected from 1995 to 2024 5 years
Secondary measurement of the ability of these viruses to replicate in the presence of Wolbachia infection of cell lines with virus strains isolated and amplified from patient blood samples collected from 1995 to 2024 5 years
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