NCT03552094

Brief Summary

The dengue, Zika and chikungunya arboviruses represent potentially severe infections to which the New Caledonian population is exposed. In the absence of specific treatment or vaccine, vector control remains the method of choice to limit their spread. However, the traditional methods of prevention and vector control measure today face their limits: mosquito resistance to insecticides, difficulty of access and destruction of breeding areas... The World Mosquito Program Noumea project is based on the artificial colonization of the mosquito vector Aedes aegypti by the endosymbiotic bacteria Wolbachia, which reduces its ability to transmit arboviruses. The breeding of mosquitoes carrying the bacterium Wolbachia in the laboratories of the Institut Pasteur of New Caledonia requires the use of human blood samples for mosquito gorging. The objective of the research is to generate, maintain and amplify Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria for the planned insect release program in Noumea.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 28, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

4.9 years

First QC Date

May 28, 2018

Last Update Submit

February 14, 2022

Conditions

Keywords

Arbovirus

Outcome Measures

Primary Outcomes (2)

  • Generation of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria

    Generation of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria for the planned insect release program in Noumea by measuring the Aedes aegypti female gorging rate

    36 months

  • Maintenance and amplification of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria

    Maintenance and amplification of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria for the planned insect release program in Noumea by measuring the number of eggs per Aedes Aegypti female gorged

    36 months

Secondary Outcomes (1)

  • Vector competence assessment of the different Aedes aegypti Caledonian lineages

    36 months

Study Arms (2)

Hemochromatosis or polycythemia patients

Blood samples from hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications. Blood bag (volume of blood: from 450 to 500 mL).

Other: Blood donations of hemochromatosis or polycythemia patients

Healthy donors

Blood samples from healthy donors. Blood bag (volume of blood: from 450 to 500 mL).

Other: Blood donations of healthy donors

Interventions

Blood samples are from blood donations of hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications.

Hemochromatosis or polycythemia patients

Blood samples are from blood donations of healthy donors.

Healthy donors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications, and healthy donors.

You may qualify if:

  • All adult hemochromatosis or polycythemia patients or healthy donors have given their written consent to participate in the study and for the collection of a blood sample.

You may not qualify if:

  • Participation refusal
  • Minor person
  • Positive result by Reverse transcription polymerase chain reaction RT-PCR for arboviruses
  • Invalid qualification of the blood donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Nouvelle-Calédonie

Nouméa, Nouvelle-Calédonie, 98 849, France

RECRUITING

MeSH Terms

Conditions

Arbovirus Infections

Condition Hierarchy (Ancestors)

Vector Borne DiseasesInfectionsVirus Diseases

Study Officials

  • Frédéric Touzain

    Hospital Center of New Caledonia

    PRINCIPAL INVESTIGATOR
  • Myrielle Dupont-Rouzeyrol

    Institut Pasteur of New Caledonia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Richard

CONTACT

Nicolas Pocquet

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 11, 2018

Study Start

June 25, 2018

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations