Arbovirus InfectionsDENWOLUTIONNCT04615364
Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia
An observational study of Arbovirus Infections and Dengue, run by Institut Pasteur at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Arbovirus Infections, Dengue, Zika
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2020to 17 Jul 2025
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient infected by arboviruses
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Territorial
Dumbéa Sur Mer, Nouvelle-Calédonie, 98 835
Ann-Claire Gourinat, MD, +687 208000, ann-claire.gourinat@cht.nc
About this study
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.
Read more
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.
Read the detailed 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
- Conditions
- Arbovirus Infections, Dengue, Zika, Chikungunya
- Keywords
- New Caledonia
- Medical subject headings
- Arbovirus Infections, Dengue, Zika Virus Infection, Chikungunya Fever
What is being measured
The primary outcome is the main question the study is designed to answer.
arbovirus genome sequencing
Whole genome sequencing of virus extracted of blood samples from patients collected from 1995 to 2024
Measured: 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
Measured: 5 years
Secondary outcomes (2)
measurement of the impact of Wolbachia on the virus genetic evolution
comparison of viral genomes extracted from blood samples collected from 1995 to 2024
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start17 Jul 2020
- Primary completion17 Jul 2025 (estimated)
- Study completion17 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arbovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe 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
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie
- Responsible party
- Sponsor
- Investigators
- Myrielle Dupont-Rouzeyrol, PhD, Principal investigator, Institut Pasteur de Nouvelle-Calédonie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615364
- Sponsor's protocol ID
- 2019-022
- Acronym
- DENWOLUTION
- Status last verified
- May 2024
- First submitted
- 29 Oct 2020
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33686914
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Evolution of Arboviruses in New Caledonia Between 1995 and 2024 and Impact of Wolbachia
- ClinicalTrials.gov ID
- NCT04615364
- Acronym / sponsor ID
- DENWOLUTION / 2019-022
- Conditions
- Arbovirus Infections, Dengue, Zika, Chikungunya
- Keywords
- New Caledonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 17 Jul 2025 (estimated)
- Study completion
- 17 Jul 2025 (estimated)
- First posted
- 4 Nov 2020 (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.
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.
Detailed 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
Study design
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient infected by arboviruses
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
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
arbovirus genome sequencing
Time frame: 5 years
Whole genome sequencing of virus extracted of blood samples from patients collected from 1995 to 2024
genetic evolution of arbovirus strains
Time frame: 5 years
bioinformatical analysis of the genome of the strains of arbovirus contained in serum samples collected from 1995 to 2024
2 secondary outcomes
measurement of the impact of Wolbachia on the virus genetic evolution
Time frame: 5 years
measurement of the ability of these viruses to replicate in the presence of Wolbachia
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 33686914Inizan 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.
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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.
Myrielle Dupont-Rouzeyrol, PhD principal investigator
Institut Pasteur de Nouvelle-Calédonie
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 Dengue, run by Institut Pasteur 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 3 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 23 May 2024. 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 Myrielle Dupont-Rouzeyrol, PhD (+687 27 75 30, mdupont@pasteur.nc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arbovirus genome sequencing (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615364, which also lists 1 linked publication.
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 23 May 2024.