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| Name | Class |
|---|---|
| Institut Pasteur de la Guyane | UNKNOWN |
| Centre Hospitalier Andrée Rosemon de Cayenne | UNKNOWN |
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In French Guiana, malaria is endemic and two species predominate: P. falciparum and P. vivax. The treatments against Plasmodium vivax malaria are: nivaquine for 3 days against circulating blood parasites and primaquine for 14 days against parasites dormant in the liver. Primaquine can cause iatrogenic hemolytic anemias in patients with favism, i.e. G6PD deficiency. This anemia can be severe enough to cause the death of the deficient patient. Thus, the WHO and HCSP recommendations indicate that a quantitative assay of the activity of this enzyme should be carried out before its prescription. This deficiency is a recessive inherited disease linked to the X chromosome characterized by more or less low levels of enzymatic activity which depends on the genotype of the patients but not only because the phenotype depends on the level of activation of the X chromosome for each cell.
Currently, obtaining a G6PD assay in French Guiana is a long process since it is done in mainland France and the pre-analytical conditions are quite demanding. Thus, in areas of transmission of P. vivax, patients usually have a bout of revival before being prescribed primaquine. This period includes: dosing G6PD at a distance from access, obtaining the result and then the nominal ATU to finally obtain and deliver the primaquine.
This is a interventional,prospective, multicenter, cross-sectional and comparative study.
To achieve this study, the following will be done:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participants selected according to their G6PD activity | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood samples (venous and capillary at the fingertip) | Diagnostic Test | For each participant, the intervention will be a fingertip sample to perform the STANDARD G6PD test and two blood samples on EDTA to perform the reference test |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the STANDARD G6PD test | The sensitivity and specificity will be calculated for the detection of severe deficits in G6PD activity (<30%), intermediate activities (30-80%) and normal activities (> 80%) of the STANDARD G6PD test vs the reference enzymatic method | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Verification of the analysis method by the STANDARD G6PD test several times | Measurement of the G6PD activity will be done to assess the repeatability, accuracy or trueness of the STANDARD G6PD test according to the recommendations of standard NF EN ISO 15189: 2012 for accreditation. | 3 years |
| Verification of the analysis method by the STANDARD G6PD test by different operator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Musset, PharmD | Contact | +335 94 29 68 40 | lmusset@pasteur-cayenne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Lise Musset, PharmD | Institut Pasteur de la Guyane, head of Parasitology laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Pasteur de la Guyane | Recruiting | Cayenne | French Guiana |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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150 participants selected according to their G6PD activity:
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Measurement of the G6PD activity will be done to assess the inter-operator variability, of the STANDARD G6PD test according to the recommendations of standard NF EN ISO 15189: 2012 for accreditation. |
| 3 years |
| Verification of the analysis method by the STANDARD G6PD test in different conditions | Measurement of the G6PD activity will be done to assess the reproducibility, robustness and measurement interval of the STANDARD G6PD test according to the recommendations of standard NF EN ISO 15189: 2012 for accreditation. | 3 years |
| sequencing of the coding regions of the G6PD gene of 150 individuals | Analysis of the genotype of the G6PD gene and comparison to the phenotype | 3 years |
| D000079426 |
| Vector Borne Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |