NCT02903706

Brief Summary

Malaria is the most widespread parasitic illness in the world, and it is endemic to Guiana. Although the number of cases has decreased since 2005, sources of infection still remain, particularly within illegal gold mines. These malaria carriers/sufferers often use self-medication to deal with malaria symptoms, resulting in a risk of resistance to anti-malarial treatments, and particularly to artemisinine. The mobility of this population across the Guiana Shield increases both the risk of malaria spreading and the resistance of this illness to treatment in the region, and puts the population at risk of new outbreaks of this disease despite the great efforts put into anti-malarial policy in this region. Fighting malaria within this population is therefore a dual public health challenge: on the one hand, make it possible for the WHO to eliminate malaria from the Guiana Shield by 2017, on the other to limit resistance to artemisinine in this region. However, Guiana's particular context - namely the illegal status of gold mines and the difficult geographical access, the Harpie military operations, the illegality of carrying out malarial diagnosis tests and treating cases without the presence of a health professional - prevents us from achieving this goal using the same tools as our neighbours in Suriname, whose " Looking for Gold, Finding Malaria " programme was a success. A better understanding of the malarial epidemiology in this population will enable us to propose innovative, more adapted measures to combat malaria within these guyanese populations. This is an transversal, multicentric observational study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
421

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Status
completed

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

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

September 7, 2016

Last Update Submit

September 13, 2016

Conditions

Keywords

gold minersplasmodium carriersartemisinine resistance

Outcome Measures

Primary Outcomes (1)

  • prevalence of malaria positive individuals (symptomatic or not symptomatic)

    every participant gives a capillary blood specimen which is then screened for malaria using PCR in order to obtain a prevalence of malaria positive individuals (symptomatic or not symptomatic)

    1 month

Secondary Outcomes (1)

  • Microscopy: thick and thin smear

    1 month

Interventions

Eligibility Criteria

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

People working on illegal gold mining sites in French Guiana.

You may qualify if:

  • works on a gold mining site in French Guiana
  • has been at the resting site for less than seven days
  • is over the age of 18
  • accepts to take part in this study

You may not qualify if:

  • refuses to take part in the study
  • is under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Douine M, Mosnier E, Le Hingrat Q, Charpentier C, Corlin F, Hureau L, Adenis A, Lazrek Y, Niemetsky F, Aucouturier AL, Demar M, Musset L, Nacher M. Illegal gold miners in French Guiana: a neglected population with poor health. BMC Public Health. 2017 Jul 17;18(1):23. doi: 10.1186/s12889-017-4557-4.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample (5 ml) for Plasmodium PCR

MeSH Terms

Conditions

Malaria

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 16, 2016

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 16, 2016

Record last verified: 2016-09