MalariaORPALNCT02903706
Prevalence of Malaria Parasites in People Working in Illegal Gold Mining in French Guiana
An observational study of Malaria and Epidemiology, run by Centre Hospitalier de Cayenne.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria, Epidemiology
- What is being tested?
- Measure of Plasmodium prevalence (PCR)
- How many people
- 421 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jun 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People working on illegal gold mining sites in French Guiana.
Who may be able to join
- 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
Who cannot join
- refuses to take part in the study
- is under the age of 18
About this study
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.
Read the detailed description
Main Aim:
To estimate the prevalence of Plasmodium carriers in the population of illegal gold mine workers in French Guiana.
Secondary aims:
Evaluate the proportion of different Plasmodium species affecting this population and
- Determine parasitaemia levels;
- Evaluate the gametocyte index;
- Map the number and proportion of P. falciparum cases for the different river sites where gold mining is carried out;
- Determine the lifestyle, knowledge, attitude and behaviour of these populations concerning malaria;
- Estimate the prevalence of mutations linked to the resistance of parasites to artemisinine derivatives;
- Analyse the global genetic diversity of these parasites.
- Evaluate the global health of gold miners
The results of this study will make it possible to characterise the malaria epidemic in illegal gold-mining sites across French Guiana, evaluate the size of the human reservoir and the prevalence of ACT-tolerant parasites, identify the most urgent areas to be dealt with, suggest appropriate plans of action for this, and adopt more efficient public information campaigns.
Target Population: People working on illegal gold mining sites in French Guiana.
Inclusion Criteria:
- 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
Exclusion Criteria:
- refuses to take part in the study
- is under the age of 18
The sampling of the 240 people needed for this study will be achieved through chance meetings and the resulting snowball effect at gold mining resting sites on the Surinamese banks of the Maroni river.
Study Protocol:
- Acquisition of authorisations from the competent French authorities
- Authorisation from the competent Surinamese authorities
- Recruitment of one mediator/translator, one state registered nurse and one doctor
- Collaboration with Dr Cairo (program "looking for gold, finding malaria) in Suriname to plan the field missions
- Teams from Suriname and French Guiana will work joinly in the field: eligible persons will be enrolled in the study, the others can be tested by the Surinamese team.
- Inclusion of subjects through chance meetings and the snowball effect at resting sites
- Consent of patients and checking of inclusion criteria
- Performance of three diagnostic tests for each person, including
- an RDT on site
- If the RDT is positive: complete treatment given to patient following national guidelines;
- If necessary, provision of a results sheet describing the necessary doses for treatment;
- Performance of thick and thin blood smears for transport to the CHAR parasitology laboratory for analysis;
- Collection of a 5ml (EDTA) tube of blood d'un tube de sang de 5ml reserved in an icebox between 4°C et 10°C for the CNR malarial parasitology lab at the Institut Pasteur de la Guyane;
- Completion of the questionnaire;
- Temperature is taken;
- Patient is provided with a brochure about malaria in Portugese and/or Sranantango;
- Provision of an insecticide-treated net.
- Conditions
- Malaria, Epidemiology
- Being tested
- Measure of Plasmodium prevalence (PCR)
- Keywords
- gold miners, plasmodium carriers, artemisinine resistance
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of Plasmodium prevalence (PCR)Other
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month
Secondary outcomes (1)
Microscopy: thick and thin smear
Each participant is screen for malaria using classic microscopy on thin and thick smears in order to obtain a prevalence of malaria positive individuals and to evaluate parasite quantities, and gametocyte carriage (transmission potential). If either thin or thick smears are positive then the patient is estimated to have smear positive malaria.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
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 MalariaStudies of the same condition, open and under way.
- 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
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903706
- Sponsor's protocol ID
- ORPAL
- Acronym
- ORPAL
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28716015
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Malaria Parasites in People Working in Illegal Gold Mining in French Guiana
- ClinicalTrials.gov ID
- NCT02903706
- Acronym / sponsor ID
- ORPAL / ORPAL
- Conditions
- Malaria, Epidemiology
- Keywords
- gold miners, plasmodium carriers, artemisinine resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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.
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.
Detailed description
Main Aim:
To estimate the prevalence of Plasmodium carriers in the population of illegal gold mine workers in French Guiana.
Secondary aims:
Evaluate the proportion of different Plasmodium species affecting this population and
- Determine parasitaemia levels;
- Evaluate the gametocyte index;
- Map the number and proportion of P. falciparum cases for the different river sites where gold mining is carried out;
- Determine the lifestyle, knowledge, attitude and behaviour of these populations concerning malaria;
- Estimate the prevalence of mutations linked to the resistance of parasites to artemisinine derivatives;
- Analyse the global genetic diversity of these parasites.
- Evaluate the global health of gold miners
The results of this study will make it possible to characterise the malaria epidemic in illegal gold-mining sites across French Guiana, evaluate the size of the human reservoir and the prevalence of ACT-tolerant parasites, identify the most urgent areas to be dealt with, suggest appropriate plans of action for this, and adopt more efficient public information campaigns.
Target Population: People working on illegal gold mining sites in French Guiana.
Inclusion Criteria:
- 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
Exclusion Criteria:
- refuses to take part in the study
- is under the age of 18
The sampling of the 240 people needed for this study will be achieved through chance meetings and the resulting snowball effect at gold mining resting sites on the Surinamese banks of the Maroni river.
Study Protocol:
- Acquisition of authorisations from the competent French authorities
- Authorisation from the competent Surinamese authorities
- Recruitment of one mediator/translator, one state registered nurse and one doctor
- Collaboration with Dr Cairo (program "looking for gold, finding malaria) in Suriname to plan the field missions
- Teams from Suriname and French Guiana will work joinly in the field: eligible persons will be enrolled in the study, the others can be tested by the Surinamese team.
- Inclusion of subjects through chance meetings and the snowball effect at resting sites
- Consent of patients and checking of inclusion criteria
- Performance of three diagnostic tests for each person, including
- an RDT on site
- If the RDT is positive: complete treatment given to patient following national guidelines;
- If necessary, provision of a results sheet describing the necessary doses for treatment;
- Performance of thick and thin blood smears for transport to the CHAR parasitology laboratory for analysis;
- Collection of a 5ml (EDTA) tube of blood d'un tube de sang de 5ml reserved in an icebox between 4°C et 10°C for the CNR malarial parasitology lab at the Institut Pasteur de la Guyane;
- Completion of the questionnaire;
- Temperature is taken;
- Patient is provided with a brochure about malaria in Portugese and/or Sranantango;
- Provision of an insecticide-treated net.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People working on illegal gold mining sites in French Guiana.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- refuses to take part in the study
- is under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of Plasmodium prevalence (PCR) | Other | – |
Primary outcome
prevalence of malaria positive individuals (symptomatic or not symptomatic)
Time frame: 1 month
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 secondary outcome
Microscopy: thick and thin smear
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Derived from this study: PubMed 28716015Douine 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Epidemiology, run by Centre Hospitalier de Cayenne.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of malaria positive individuals (symptomatic or not symptomatic) (time frame: 1 month). 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 NCT02903706, 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 16 Sep 2016.